Welcome to FinTech TV.
I'm Remy Blair.
CNI Diagnostics is on a mission to change the way that LM are diagnosed and managed.
They used an innovative test called the CNIA platform, and the tech gives doctors better tools to make informed treatment decisions and is a big step forward in precision diagnostics for CNS.
And just recently, UnitedHealthcare approved reimbursement for CNI.
Well, joining me today at the New York Stock Exchange is Dr.
Mark Hedrick, president and CEO of Plut Therapeutic.
Doctor, thank you so much for joining me.
Hi Remy.
Good morning.
Good morning.
Well, first and foremost for our audience, explain exactly what LM is.
So there's actually an epidemic of this thing called LM or leptomeningeal metastasis, and As doctors and healthcare providers, we're doing a better and better job taking care of patients with breast cancer, lung cancer, melanoma.
And those survivals are getting better, but those cancer cells will escape the breast, escape the lung, and get one or two cancer cells in the fluid around the brain, and patients, once they're diagnosed, live about 4 weeks without treatment.
About 5 patients go to hospice.
And then the ones that get treated last maybe 4 months on average, but there are no approved drugs.
So there's a problem therapeutically, but there's also a problem diagnostically.
And so that's where CII comes in.
It's a one stop, 4 in 1 test and confirms a diagnosis.
It tells you whether your disease is getting worse or better.
It tells you what drug to use or what drug not to use, and it tells you if you're getting better after treatment.
Yeah, and we know that time is of the essence when we're talking about diagnoses.
So tell us how what you're doing over at ATSN inside the mission.
How does it fit into the overall strategy over at Plus Therapeutics?
Yeah, so SinNI is a subsidiary of the parent company Plus Therapeutics, and so our sole mission in life is to bend the curve on survival for brain and central nervous system cancers.
Why is that so critical?
If you go back over 40 years, you take all cancers that aren't the brain and aren't the spinal cord.
There's about a 300% improvement in survival, 40 years, everything's getting better except brain cancers and central nervous system cancers.
The survival curves are flat and so to bend that curve, what we're taking a novel approach.
We're not doing the same way people did it for 4 years.
We're throwing out the playbook.
And we're starting over and basically we're building a tech agnostic company devoted to bend the curve and that's looking at new diagnostics like CSI, new therapeutics like targeted radiotherapeutics, and then we're going to be collecting and are starting to collect a tremendous amount of data on these patients and so there's a real data analytics opportunity as well.
Yeah, and tell us a little bit more about the opportunity here at the New York Stock Exchange.
We might focus on data in terms of what it means for investments, but when we're talking about something as crucial as healthcare, give us more insight into this.
Well, if I could take a step back from see Insight for a moment and I'll come back to it, but we have a targeted radiotherapeutic that's a drug that delivers all of its radiation to the tumor and then it's absorbed by the body.
You don't get any untoward effects elsewhere in the body.
Well, the delivery of that is very tech intensive.
It's imaging intensive.
And there are even they're models that are used to sort of figure out how to appropriately place that to get the best outcomes.
That's a, that's a great opportunity for artificial intelligence in looking at data on imaging to improve the delivery.
So now that's just for our drug for glioblastoma, which is the most common primary brain cancer.
But for CNI.
The current and let me give you an important comparator, so the current state of the art for diagnosing cancer cells in the fluid around the brain was first initiated in 1904.
That's the competition And so the one reason those survival curves are so flat for brain cancers is the diagnostics are poor.
So CNI collects a tremendous amount of data on the tumor cells that are there, what they express, what genes are turned on or turned off, what the overall genomic profile of the patient might be. whether they assess whether a particular drug might work or might not work and so they suggest treatment pathways for patients and they help to monitor that treatment.
So that's a tremendous amount of data coupled with other data we get from imaging and from our therapeutic, and that really kind of goes into a bit of a flywheel where we have diagnostic information, you have therapeutic information, we evaluate that and that tells us what to do with the diagnostic and then tells us what to do with the therapeutic.
So the, the goal is to create that flywheel that ultimately bends that curve up and improves survival.
Yeah, and when we look back and think about 1904, the year right now is 2025, so it's obviously been over a century here.
But as you look ahead, give us an idea of how you see the inside diagnostics evolving in the coming years to address some of these challenges.
So, so, so we actually acquired CSight.
It had already been commercial and it had done about 1000, excuse me, 11,000 commercial tests, and we had the opportunity to acquire it.
So from, from, you know, putting on my business hat, I mean it was a completely de-risked asset.
It had been commercial.
It had had reimbursement.
It had about 200 providers in the US that were using it, and that was based at the time on very little clinical data.
So once we acquired it, we immediately began to develop data sets to show its value in the hospitals and clinics and so forth for physicians and patients.
We began publishing that.
It's now in the National Comprehensive Cancer Center.
Guidelines it's sort of now the recommended tests for patients that have LM, which you talked about before, and also useful in treatment monitoring.
So by by getting that data out there again back to data, getting that data out there published, getting it in the guidelines, and then now. getting payers back on board after our acquisition of that is critical, you know, to really get it out there and get it, get it reimbursed and allow us to begin to get that flywheel running in terms of, you know, diagnostics, therapies, and then improving those over time.
And doctor, finally, before I let you go, you've given us insight into both the health side of this as well as the business side.
But when we're talking about something as crucial as health care, we know that the regulatory landscape also comes into play.
So what is your vision moving forward from a regulatory perspective?
Yeah, so first of all, from the diagnostic side and CNI is regulated under CMS Center for Medicare and Medicaid Services, not the FDA.
We just recently announced that our laboratory, the test is performed at a central laboratory, has been accredited by CMS, which allows us now to build not only, you know, Medicare and, and it allows us to open up the whole payer network, you know, as broadly as one can.
And so getting that accreditation has been, has been critical, but there's from a sort of a risk management perspective for an investor, there's no sort of FDA sort of binary readout on a clinical trial.
It's been commercial.
The payers are coming back on board.
We've optimized reimbursement and then we're building a laboratory that can really Address any demand scenario that one could imagine with that.
That's that's sort of the diagnostic part of that on the on the therapeutic side.
Yeah, those pathways do go through FDA.
However, they're rare disease pathways.
You get a certain number of benefits like orphan designation, fast track, accelerated approval.
We finished our phase one for our lead drug Rahaobic for patients that have this epidemic of LM or lepto meningeal cancer.
And so we'll be in Q4.
We'll be in front of the FDA.
We'll be talking about how we, you know, what's the optimal pathway to get that drug approved, because there is nothing approved for these patients.
Doctors throw the kitchen sink at these, these patients, and you really don't improve survival too much.
OK, well, I really appreciate your time, doctor.
Thank you so much for shedding light on this important topic and for your insights and perspect.
Thank you, Remy.
