Interview with Neurotech International (ASX:NTI)

Neurotech International

We spoke with Dr. Alex Andrews, CEO of Neurotech International (ASX:NTI), about the great data her company has recently received from a study of its NTI164 product in Autism Spectrum Disorders (ASX) and the potential of the upcoming Phase II/III trial.

NTI164 is the first ever first full-spectrum medicinal cannabis product to be successfully studied in children with ASD.

See full transcription below.

 

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Transcription

 

Stuart: Hello, and welcome to Stocks Down Under. My name is Stuart Roberts, and I’m one of the co-founders of our publication. And joining me from Perth, on the afternoon of Wednesday, the 13th of July 2022 is Dr. Alex Andrews, who’s the relatively new CEO of Neurotech International, ASX:NTI. Alex, good afternoon.

Dr. Andrews: Hi Stuart.

Stuart: So, Alex, you’ve got probably the biggest piece of clinical data of any life sciences company on ASX this year. Neurotech International has been working for a while now on a particular kind of medicinal cannabis that you in-licensed to the company. I think it was two years ago. You’ve just got some great data in the autism spectrum disorders. Share with us what NTI164 has been able to do for a bunch of kids with moderate to severe autism.

Dr. Andrews: So, our product NTI164 is a unique strain of medicinal cannabis that naturally contains really high levels of CBDA and it contains little to no THC. So that’s an important combination and an important foundation to start with. We have used this drug NTI164 in a population of children with moderate to severe autism and shown that we were able to reduce their symptoms in 93% of that population.

Stuart: I’m guessing it’s not possible to get P less than 0.05, but when you drill down to the details of that data, what particularly impressed you amongst that 93%?

Dr. Andrews: It was showing that they had such a reduction in the symptoms from baseline. So, the professor Michael Fay and his clinical research team really assessed these kids, firstly, without any medication, and established their personal baselines. This was then compared to their performance when they were taking, after they’d been taking the drug for some time. So, showing that, comparing your baseline to post baseline, we were actually able to get a statistically significant effect.

Stuart: I’m sure you had some champagne that night, once the data came out, because we’re talking, a P equals less than 0.05 in a patient population that small. Everyone who knows this particular condition ought to be sitting up and taking notice. At the moment if families have a child with autism, there’s nothing much they can do with those kids other than cognitive behavioral therapy, I’m guessing.

Dr. Andrews: Yeah, that’s it. Well, that’s definitely an important element of their care.

Stuart: Which is expensive too, right?

Dr. Andrews: Of course, it is, yeah, but necessary. I think it’s definitely an important part of the therapy process. In terms of the drugs that are available to them, there’s very little options available. Currently, the only FDA approved drug is called risperidone and that’s an antipsychotic with some pretty horrific side effects, including things like weight gain and all sorts of things. So, it’s not desirable, but that’s all they’ve got.

Stuart: Survey the parents of these kids, and no one wants to put their kid on risperidone unless it’s absolutely necessary, right?

Dr. Andrews: Even the doctors don’t like prescribing it.

Stuart: Right. Now, those of us who know the medicinal cannabis space know the terms CBD and THC. THC is obviously the stuff that gives stoners their high. CBD is the good stuff, which has a range of potential benefits, including, for instance, pain reduction and so forth. You talked about CBDA, which I understand is almost a trace element in cannabis indica. Talk to us about CBDA and why it’s important in this condition.

Dr. Andrews: So, CBDA is a minor cannabinoid. As you say, it’s considered a trace element in most other plants out there. However, we’ve got this very unique strain of medicinal cannabis that naturally produces really high levels of CBDA and we believe that’s the secret ingredient to our recipe. And, yeah, again, it contains little to no THC, which is the part that gets you high.

Stuart: Now, Alex, you’ve got a big problem ahead. You’ve gotta go and talk to various regulators about how they should regard your product in a condition, as you say, where there’s not much drug therapy available. And obviously, the regulators are still figuring out how properly to regulate the medicinal cannabis products. Talk to us about some of the challenges you think you’ll face as we scale up to, I’m guessing a phase II, III from here, given the phase II data was so good.

Dr. Andrews: Absolutely. We’re getting ready to start our phase II, III trial, and we’ve got a really clear roadmap when it comes to the USFDA. We’ve got some fantastic consultants in the U.S. with their boots on the ground. We’ll be going off to Washington later in the year to have a face-to-face meeting with the U.S. FDA and get their sign off on our roadmap.

Stuart: Right. Are they gonna give you some challenges, for instance, in terms of manufacturing? Any cannabis product is gonna be complicated and obviously guaranteeing batch-to-batch consistency is gonna be an issue. So, how are we gonna manage those challenges when we talk to agencies like the FDA?

Dr. Andrews: So, all of the manufacturing is done with licenses through the appropriate centers for drug control. And in terms of batch-to-batch consistency, we do need to maintain within a certain specification of these ingredients, but we’ve so far had no trouble doing that. So, we’ve been showing very consistent batch-to-batch product consistency.

Stuart: Okay. So, now talk to us about the timeline of the phase II, III. I suspect it’s not gonna be too difficult to find treatment centers willing to participate in the study. What’s your preliminary thinking about size of the trial and what sites would be involved?

Dr. Andrews: At this point, they’re gonna do it at the Monash Children’s Hospital, again, with Professor Michael Fay. The actual exact number of participants is still yet to be finalized, but we do have an extensive growing list of over 150 families who have registered their interest already. So, we’ll have no trouble recruiting. And that’s an important part because a lot of other clinical trials have a lot of difficulty when it comes to finding the right participants who are willing to dedicate their time and energy into participating in a trial. But we have got such an overwhelming interest from the population.

Stuart: Right. And the agency, as in the FDA, in this case, is comfortable with a single site, on the other side of the world. Ordinarily, they like to have more sites in their own country, for example. I mean, not ordinarily, every case is different, but I’m surprised that they’re happy with just a single site that’s not in the United States.

Dr. Andrews: The FDA is really concerned with two things, that is, safety and efficacy. If you’ve got the data that backs up these things, the FDA doesn’t have a problem.

Stuart: All right. That’s exciting. Now, really puzzling, the share price didn’t react to this one. What do you think the market is missing other than the fact that we’re in a bit of a life sciences bear market at the moment?

Dr. Andrews: Look, Stuart, you understand the markets better than I do. I don’t know what the market’s missing on this one. I think it’s a really great opportunity.

Stuart: Right. Well, okay. Let me summarize it and jump in if I miss something here, Alex. Investors out there, you need to pay attention to Neurotech International, because they’ve just got some really compelling data in a disease condition that potentially affects 1 in 100 of us. How many you say?

Dr. Andrews: One in 44 kids in the U.S.

Stuart: Okay. There you go. The numbers move around affair bit, but we’re talking a billion dollar market opportunity, with no drug therapy. In this case, with no side effects and 93% of the children in this case responded, and yet you didn’t wanna buy this stock. Maybe after this interview, you might go back and look at what a ridiculous market cap Neurotech is showing. Now, Alex, did I tell the story as you would tell it?

Dr. Andrews: Yes, Stuart. Well done.

Stuart: Now, Alex, for investors who don’t know you very well. Some of you who’ve invested in another company, ASX:NSB, Neuroscientific Biopharmaceuticals may have met you previously. Before that, you obtained your PhD at the University of Western Australia in Professor Ziman’s laboratory. Tell us about your career and what’s brought you to Neurotech.

Dr. Andrews: Yeah, so I did my PhD at the School of Pediatrics in Child Health at UWA. I’ve always been very interested in kids’ brain development. So, Neurotech is right up my alley. And I then worked at Linear Clinical trials where I was involved with going off to the U.S. a lot to try and encourage the U.S. biopharma companies over there to do their clinical trials in Perth.

Stuart: In Perth, because obviously, it’s a lower cost opportunity than what a lot of these Americans are paying back home, right?

Dr. Andrews: Yeah, absolutely. Take advantage of the R&D tax incentive and you can do it a lot faster in Australia compared to some of the timelines in the U.S. So, there’s definite advantages to doing your trials in your early phase, particularly, in Australia. And I learned a lot through that role in terms of clinical trial design and understanding how these biotechs work. So, that put me into good stead for working at NSB for the next few years, where I was director of operations and then was approached by NTI recently, and I’ve joined as the CEO.

Stuart: Right. And, I mean, obviously, it’s been a fast loading curve for you, but you’ve got some great help there. You’ve got…Brian Leedman is your chairman. Many people who know the life sciences space will have met Brian in some of his previous very successful roles, including ResApp. Talk to us about some of the other strengths of the board that you’re working with at NTI.

Dr. Andrews: We’ve got Professor Allan Cripps, who is a professor emeritus at Griffith University, an incredibly distinguished scientist and wealth of knowledge when it comes to all thing’s medicinal cannabis. And I’ve got Krista Bates, who’s an ex-partner at Lavan Legal. We’ve got Winton Willesee and Mark Davies, who have got extensive backgrounds around finance and business, corporate governance. So, very well rounded board. Oh, I nearly forgot our most recent appointment of Gerald Quigley. And Gerald comes from a background of pharmacies. So, he’s got extensive arrangements around how to progress this drug through the U.S. FDA, but also the TGA here and also a background in media. He does all sorts of TV appearances and radio.

Stuart: Okay. So in terms of the timeline of getting ready for phase II, III, when do you hope to be dosing your first patient? Obviously, its early days, but what would be ideal?

Dr. Andrews: Ideally, we’ll start in Q3 this year.

Stuart: Okay. Great. It’s a busy timeline. I’m surprised you even have time to talk to Stocks Down Under. Alexandra, well done on what you and your colleagues have achieved, as it’s very exciting. And here’s to the next stage of the journey and particularly, that phase II, III, bringing it together.

Dr. Andrews: Thank you, Stuart.