Revolutionizing Brain Cancer Treatment: Insights from Dr. Marc Hedrick of Plus Therapeutics

Welcome to FinTech TV.

I'm Johnny Fernandez, and I'm here with Dr.

Marc Hedrick, the President & CEO of Plus Therapeutics.

Doctor Hedrick, thank you so much for joining us today.

First question to start off with, um, what does Plus Therapeutics do and who are you trying to help?

We're trying to help patients with brain cancer.

It's an area that's been orphaned really over the last 40 years.

In fact, there's been essentially no improvement in survival over the last 50 years in brain cancers.

So we're trying to bring to bear therapeutics, diagnostics, and advanced data analytics to finally improve that survival curve for patients with brain cancers.

So let's talk about your lead therapy.

It's Ray Obi.

So, let's talk about what exactly it does and how it's actually changing what you guys are doing in the medical space and the healthcare space.

So, Even though there haven't been much in the way of improvements in survival for brain cancer, the thing that has worked the best is radiation.

So Rayobic is a drug that delivers very high doses of radiation, 20 times then that that can be delivered with current technology, and it delivers it directly to the, the brain cancer.

And has essentially zero effects to the rest of the body.

And so we have recent news that we received a CPT-3 code from the American Medical Association for the delivery of our drug that just ensures that it goes to the tumor and not to the rest of the body.

So let's talk about that new code.

So why is that important specifically for the patients and along for the company, because this is big news that we have, especially for this area in healthcare.

Yeah, and the code's not just for us, it's for the whole field, but it allows, uh, allows tracking and billing for physicians to do something called convection enhanced delivery, which is a key to the utility of our drug.

Our drug needs to get to the tumor, and the way it gets to the tumor is through this technique called convection enhanced delivery.

It's sort of a minimally invasive neurosurgical procedure.

But having that coding is key, both for us to run an approval trial, which we're, we, we're on track to do next year, uh, but getting that in place is really key to open up the delivery opportunity for us, for our drug Robic.

So, let's talk about this meeting that you recently had with the FDA about treatments for serious types of cancer.

What were the meetings about and what feedback did you get for uh the company?

So we had a meeting in November with the FDA, and our lead drug Robic, which I just mentioned, is also in the clinical development process for leptom meningeal cancer, which is increasingly common metastatic cancer complication of common cancers like breast cancer, melanoma, lung cancer.

So we, there are no approved drugs for leptto meningeal cancer.

So we went to the FDA.

And with some questions and working with the FDA, we sketched out a path to approval for Rayobic for lepto meningeal cancer, which includes things like what are our trial end points, what do we compare against, how many patients, and so forth.

So we, we really got great alignment at that meeting and we really have a roadmap now so we can execute towards an approval trial next year.

So let's talk a little bit more about that roadmap.

How did this meeting shape the path to approval?

Well, when, when there's nothing approved, um, the question is, what does that trial look like?

You really don't have other trials upon which to base your, your trial and your, your clinical development thinking.

So we took a body of data that we had developed over a course of a number of years, showing the safety of our drug, potential efficacy, how it works, mechanism of action, the pharmacokinetics, what's, how does the drug sort of flow through the body, where are the complications, and so forth, and then based on that, we developed a pathway for approval, but it, it allows us to be more efficient.

With our dollars and our timelines for clinical development, and it really effectively compresses the timeline till that approval trial.

It makes that whole process more efficient, more scripted, and it allows us to move together in concert with the agency.

So the company isn't just a drug company, it also has a diagnostic platform.

You guys are licensed in 49 states.

So let's talk a little bit about uh CN side and uh how that works and how that's also impacting the healthcare space.

Well, the reason we got into diagnostics is we recognized that part of the problem with improving survivals in brain cancers are the diagnostic options are poor.

Uh, for example, the, the diagnostic that we will compete against in the market was first introduced in 2004.

To put that in perspective, so we, so we, we developed a very high conviction around a diagnostic, uh, portfolio that we acquired about a year and a half ago that we've, we've relaunched that.

And so we have news to announce there that we, we, we recently, uh, received, uh, what's called a proprietary laboratory analysis code or PLA code, and that's a very important key to accessing the market and ultimately getting paid for the, the diagnostic.

So, let's also talk about early detection because that's obviously a game changer here and it's something that is playing a huge role.

So, how exactly uh does early detection uh create a game-changing environment for what you guys are doing?

So let me put the medical need in perspective.

There are a million Americans walking around with advanced cancers that are at risk of metastases to the brain or the fluid around the brain.

It's a lot of patients, and they have these, as I mentioned, poor diagnostic options.

And once the cancers are set up in the brain or the brain tissues, these patients progress very rapidly.

So being able to have a definitive.

A simple, a quick test that tells with a very high sensitivity whether or not brain cancer is there allows the doctors to begin to make treatment decisions much more quickly.

So, for example, our test called See Inside is actually a series of 4 tests, but the lead test can pick out 1 cancer cell and an entire tube of fluid from around the brain.

So lumbar puncture, you get the fluid out, test it.

If there's 1 cancer cell, then we'll find it.

So, yeah, that's really critical and kind of making a quick decision for, for these patients.

Uh, and that's amazing.

And I know you guys recently, you guys released a study showing about the savings in this uh entire atmosphere.

So let's talk about the savings when it comes to what you guys are providing for patients.

So, so it's one thing to have a test that's more sensitive and works better, but we, you know, it, it, it does increase the cost that the test has to be paid for.

But we, yeah, we recently announced medical economic data showing the presence of that test and how it improves patient care actually saves costs, so it saves about 40% of the cost per patient.

So if the average patient spends $700,000 in their care for their metastatic brain cancer.

We can reduce that by 40%, a significant amount of savings, particularly when we're talking about well over 100,000 patients in the US that had this, this disease.

So let's break it down even a little bit further.

Let's talk about the savings for the patient and for the payer.

Yeah.

Can you walk us through what exactly that would look like?

Well, it's for, for the, for the, for the payer, it's just addition to subtraction.

It's rather than spending $700,000 on it for the average patient and patient care.

It's something closer to 400,000 on average.

So that's, it's, it's dollars and cents for the, for the payers, and the incremental cost of the test is negligible given that overall savings for the patient, it's not about dollars and cents.

I mean these patients, once they're diagnosed, live a few weeks.

Oftentimes they go to hospice because the doctors throw up their hands and just say, we don't have really good treatments, and frankly, we don't have really good diagnose diagnostics.

In other words, Using the old diagnostics, I'm not really even sure you have this disease.

So we, you know, we solve that problem and then we translate that into more months of survival for the patient, and we can bridge them to treatment and actually our C inside will help the doctors.

Decide what therapeutic to use because in many, many cases, uh, the, the drug choice is really complex and see inside actually helps the doctor make that decision as well.

So let's talk about the future right now.

You guys have a big year.

You guys have had a big year.

So what is the rest of 2026 look like for you?

Well, I think you can looking at it in each of the areas of the business from a therapeutic perspective, it's getting our lead drug Rayobic into pivotal trials for recurrent glioblastoma, which is the most common primary brain cancer, and then getting it into an approval trial for lepto meningeal cancer, which is the most common metastatic uh tumor of the brain.

So getting into an approval trial in concert with the FDA.

Diagnostically, it's to ramp sales.

So we are now commercial with CNside.

Um, we're expanding market access.

Our goal is to get to 100 150 million covered lives.

We've got about 80 million.

Just this week we announced Blue Cross Blue Shield of California is now one of the approved payers.

So building, building that market access, a commercial access team is a critical part of, of our objectives this year.

And then, and then finally, uh, behind the scenes, we're developing an advanced data analytics platform because we're, we're, we're gathering data that nobody's ever gathered before, both diagnostically and therapeutically, and we see there's a real opportunity to build out a, uh, a product pipeline based on that unique data and our ability to to access that and use that in a, in a very rapid cycle time sort of manner.

So, so data analytics will increasingly be an important part of the story.

And what should investors be on the lookout for as key milestones this year?

Well, I think, as, as we've said for both, uh, therapeutically, it's getting into approval trials, and that's the last step before you get, uh, get approval by the FDA.

So getting into those trials is a critical thing.

So announcing, uh, uh, close out of our phase two trials, uh, is an important milestone for us therapeutically and reporting that data, uh, which we'll do later in the year, um.

But on the diagnostic side, it's, it's getting 150 million covered lives, which is our goal this year.

We think that's possible, uh, getting, building the number of cases we, we, um, we do, um, so that we begin building, you know, growing revenue and growing the number of tests and expanding our team, so.

Uh, as we expand into that, that overall market, and then there'll be some, there'll be some things we're gonna talk about from a data analytics perspective that it's really too early to sort of forecast, but, but kind of stay tuned for those.

A well, thank you so much, Doctor Hedrick.

Thanks for counting your time.

Appreciate it.

Thank you.