Bill Caragol, CFO of Mainz BioMed, was recently a guest on Benzinga's All-Access.
Mainz BioMed, maker of clinical laboratory tests, is committed to saving lives and reducing healthcare costs through early disease detection and prevention. For cancer and chronic conditions, patients can now live longer, healthier lives thanks to advances in diagnostic technology.
Mr. Caragol shared exciting info about Mainz Bio's early DETECT 2 study set to be completed in Q4 2025.
Mainz BioMed, maker of clinical laboratory tests, is committed to saving lives and reducing healthcare costs through early disease detection and prevention. For cancer and chronic conditions, patients can now live longer, healthier lives thanks to advances in diagnostic technology.
Mr. Caragol shared exciting info about Mainz Bio's early DETECT 2 study set to be completed in Q4 2025.
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00:00And it is my pleasure to welcome in the CFO of Minas Biomed, Bill Karagal. Wonderful to be with you today, Bill.
00:10Great to be with you. Thanks, Dan.
00:12Well, let's get right into it. Can you give us an overview of Minas Biomed?
00:16So Minas Biomed is focused on early detection of cancer.
00:22Our original product is launched and approved in Europe for early detection of colorectal cancer.
00:30Through the development and acquisition of several technologies, we've put together what we think is a compelling offer for a next generation product that shows in preliminary studies to have significantly improved over industry standards, significantly improved performance in the detection of advanced adenoma.
00:52And, Dan, why that's important is advanced adenoma are the polyps that come before cancer.
00:57So what we're trying to do is to move from detection to prevention by finding these growths, these precancerous lesions, before they develop into cancer.
01:09No, it's such an important thing. And, Bill, let's kind of dive a little deeper into why early detection is so important right now.
01:14Well, if you look at our primary focus, which is in colorectal cancer, in broad terms, if you detect colorectal cancer in stage one or before, there's up to a 90% probability or chance of long-term survival, which emphasizes why early detection is so important.
01:36Late-stage detection obviously has much worse outcomes.
01:41So, again, moving the spectrum, not just to early detection stage one, but being able to move to precancerous lesions and detect before they develop into cancer can drastically increase prevention, detection, and survival.
01:59And let's talk about how MindsBioMeds focus on detecting those advanced precancerous lesions potentially can transform colorectal cancer treatment from a screening-based approach to a prevention-based approach, which obviously we know is very important.
02:12Well, exactly. In 2023 and 2024, we ran three feasibility studies and just announced today that we've enrolled patient number one in our 2,000 patient average risk study to validate those results.
02:30But what those results showed is that for detection of advanced adenoma across three different populations, we were able to detect at north of 80%.
02:39Why is that important? Well, if you look at the other stool-based tests, the one that people in the United States know best, Coligard, the detection capability of their next-generation product and other similar competitors is in the 40% range, in the 40s, where our results are showing in the 80s.
02:59And then importantly, if you look at the blood-based tests, which have gotten a lot of attention over the course of the past couple of years, they detect at less than 20% for advanced adenoma.
03:11So again, when you take the step before stage one, before it turns into a cancer, we're aiming to be able to get to double the performance from 40s to 80s of the existing state-of-the-art test.
03:25Yeah, it's incredible. And listen, we are living in pretty amazing times.
03:29I wonder what advantages to the combination of mRNA biomarkers as well as AI algorithms and that traditional FIT testing offer over the current colorectal cancer screening methods right now?
03:42Well, Dan, it's kind of a build. FIT test is a standard of care in Europe and is also used. It's part of, say, the Coligard test. It tests for hemoglobin or traces of blood in a sample.
03:57That's important. That's a good test. But to build on top of that, you add genetic markers.
04:04We are one of only two right now that are using mRNA biomarkers.
04:09And then we build on top of that and use a machine learning developed algorithm to increase the performance of the underlying genetic plus FIT test.
04:21And it's the combination of those three and the underlying intellectual property we have underneath that's able to provide these differentiated results.
04:31And let's talk about if successful, what would be the timeline for this new test to become commercially available following the plan completion of that early DTEC-2 study in Q4 of 2025 and subsequent RECON-AA sense pivotal study as well?
04:44Yep. So our timeline is to complete and to read out the early DTEC-2 study that we announced first patient in today and report by the top line by the end of this year,
04:57which will allow us to move quickly into our reconnaissance, our full PMA-FBA study,
05:05which we would then do the heavy lift on enrollment during 2026, which would put us in a position to get approval and commercial launch by the end of 2027.
05:17So it's a two-year time horizon with some important milestones along the way.
05:23Absolutely. And as I mentioned, we're living in pretty incredible times.
05:27Bill, you look at AI. How is AI changing the medical industry?
05:29Well, you know what, just to diverge for a minute from the colorectal cancer screening to something that we announced just a little while ago,
05:38is that we've been working in early stage for the past couple of years developing a test for pancreatic cancer.
05:45We partnered with a group called Liquid Biosciences out in California that has a proprietary platform,
05:52an AI platform that when we engaged with them, they were working with us on our existing product,
05:59which was a stool-based product to complement our colorectal cancer screening product.
06:04We saw good results, but they did some preliminary work on some massive databases
06:10and were able to identify a new portfolio of blood-based biomarkers, mRNA-based,
06:20that we never would have been able to find by typical experiment in trial and error,
06:25or said differently, it would have taken thousands of years.
06:29But the ability of what AI can do in the medical field of being able to address these massive databases
06:36and to be able to run all of those permutations to find and optimize, in our case, not a therapeutic, but a diagnostic,
06:45what the best combination is to achieve a desired result.
06:49And then we move into the science phase of then testing, validating, and then developing the assays.
06:56Fascinating stuff.
06:57And like I said, a fascinating time to be alive.
06:59It was an absolute pleasure talking with you today.
07:01Bill, thank you so much for your time.