Cognito Therapeutics raises $100M for FDA-bound light-and-sound Alzheimer's device

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Gentlemen, how are you? Thanks so much for having me.

We're doing fantastic.

Great to have you. Thanks so much for taking the time to join us.

Big day.

Big day. Please

introduce yourself and the company.

Yeah, so uh I'm Christian Hal. I'm the CEO of Cognito. Um my background is I'm a former Navy officer and a longtime medtech

Wow.

uh executive and then the the company is um you know sort of an amazing story. It's spun out of MIT.

Yeah.

And it's uh developing a non-invasive therapeutic for driving brain activity to promote brain health and starting an Alzheimer's disease.

Yeah. uh give me the shape of Alzheimer's uh for those who might not know the scale of its impact uh in America or even globally today.

Yeah, it's it's really um unbelievable candidly. So there are about 6 million people and families in the United States that are impacted by Alzheimer's disease. There are another 15 million people that are impacted by something called mild cognitive impairment, which is the early stage. Yeah.

of of cognitive decline. Um what's even scarier is about uh 12 million of those people are undiagnosed um because there just haven't been available therapies.

Yeah.

For for patients and their families. And so in the last couple years there have been um a series of therapies that have come to market called the monoconal antibodies. But unfortunately um they're they're not indicated for patients with more advanced Alzheimer's disease and there's some risks associated with them. So, uh, yeah, almost 50 million people around the planet are impacted by Alzheimer's disease.

And is it is it fair to say that Alzheimer's has sort of like always existed, but if you go back a couple hundred years, uh, lifespans were just so short that people would die before they had the chance to fight with their brain. They were fighting with their heart basically. And now that we've extended lives, now we're grappling with brain deterioration. Is that roughly correct? I think that's exactly right. I think that we have we are entering an age where we have just made so many diseases chronic whether it's cancer, diabetes or cardiovascular disease that we are now our bodies are living longer than our brains. Yeah.

And that is why we are you know moving into this space where we're seeing more neurogeneration and and I think we're trying to remove the stigma from it. people aren't just calling it dementia or you know people are you know they're really thinking about you know why am I experiencing cognitive loss why am I seeing you know why why am I seeing loss of independence

um but you're exactly right I mean I think it I think it is be I think the next 20 years is going to be about

you know um brain health but really thinking about you know how do we preserve structure and function our brains so we can we can have our brains living as long as the rest of you know the rest of us

so you mentioned monoconal antibodies You mentioned invasive techniques.

Walk me through the spectrum of treatments, cures that are available and how you fit in.

Yeah. So, no cures um unfortunately to date. So, everyone is focused on just figuring out how we can slow the progression of the disease and and really what's happened, you know, for years is people are sort of focused on the sort of underlying pathogens, right? You hear about things like amalloid and tao

and they're actually not causing cognitive and functional loss. They are they are biomarkers of the disease. But what's actually causing the cognitive functional loss is network dysfunction. So the brain is no long think of it like a symphony. The brain is no longer able to be in harmony. And when it falls out of harmony, it's unable to drive the biology that preserves its cognition and function. And so what a brilliant group at MIT led by Leeway Sai discovered over the last several decades is that one that you can actually stimulate the brain back into harmony

and that when the brain is at a particular activity rate um that they call the gamma brand gamma band when the neurons are firing north of 40 uh hertz per second. Then what you see is you see this sort of profound biology that is driven that helps drive synapses and myelin and and really preserve brain structure and brain function. And they then learned that you could you could use an external stimulation to drive that level of activity. And actually if you stimulated the visual and the auditory cortices that would give you the most profound sort of response. And uh what ultimately then they discovered is that you could use sensory stimulation. you could use light and sound

at a duty cycle of you know 40 hertz uh that would then drive the nerves to promote that type of activity in the brain and then you would ultimately see this really profound biologic expression. So I mean it's it's an amazing

So for the so for the folks with uh with uh brains that maybe are not fully working is this a fancy hat? No, you know, it's it's a really, you know, it's it's a good question because I say all the time that I think the first principal challenge of cognto is that

the science seems too simple to be plausible, right? So, you're going to you're going to you're going to flash light and sound,

okay?

And you're going to get my brain active and that's going to drive a biology that protects the loss of cognition function, right?

And specifically, the light and sound goes through my eyes and my ears.

Eyes and ears, right? Because we want to we want to stimulate the optic nerve. Yeah, there you go. You want to stimulate the optic nerve and you want to stimulate the stibular cclear nerve in the ear.

Yes. Okay.

Right. And so light and sound are really effective at stimulating those cranial nerves.

Yes.

But what's great is because the science candidly was perceived as being sort of so simple, it meant that there had to be this massive investment in clinically validating it. Yeah.

So there's been more than a billion dollars invested between MIT and Harvard on exploring this science. We are currently um fully enrolled almost completed what is the largest non-drug uh randomized clinical trial that's ever been conducted. We're doing 673 patients

across 70 sites in the United States. We're studying them for 12 months

and we're looking to see can we preserve their cognition and function using this type of you know this type of therapy. So uh

it ultimately becomes a tailwind for us. So over 12 months uh that gentleman with the device on his head

was that how often is he how often is he wearing that for how long at what intervals? Walk me through sort of what a typical treatment program might look like.

Yeah. So the the first thing we do is we which which is exciting is we confirm that the brain responds to the therapy. So patients come in,

we give them the the the device. Yeah. the one we determine they can tolerate the light and the sound and then under an EEG we confirm that we can get the brain to 40 Hz and hold the brain at 40 Hz.

Got it.

Then they are uh they get a personalized device that they go home with. We ask patients to wear an hour a day. Okay.

Every day.

Yeah.

Um what we hear from patients is they feel empowered.

They feel like they get an opportunity. I get up. I have my coffee. 9:00 I sit for an hour. I'm doing something proactive to address my disease. And and candidly that has manifested itself in one you know in our study state we have a almost an 85 or 86% adherence meaning patients are wearing it

six days a week at least 50 minutes a day.

Yeah

we have almost 90% of patients that are when they end the study want to stay on

the therapy and go into additional studies.

Have you considered putting advertisements in it? Um, you know, it's funny you said there there is a, you know, this one was designed for AD patients, but this idea that you can use light and sound to stimulate brain activity.

I mean, it the the platform opportunity here is really interesting to think about. You know, we know we've got indication in other disease states and conditions. We're going to study those.

There's the opportunity to think about it for

um, you know,

preventative or or even, you know, sort of brain health proactivity. And then there's opportunities for us in things like sleep and stroke and and traumatic brain.

But the default path will be FDA approval uh prescribed by a doctor. Maybe they send it home with you. It's probably expensive, but insurance will cover some of that if not all. And then uh patients will be able to use this uh sort of non-invasively to treat their Alzheimer's hopefully for as long as it takes.

Exactly. Right. Right. So, we will we will read out the study in uh August. We hope to go to the FDA in November.

The hope is that we see an approval mid of next year. You're right. We'll work with CMS to make sure that it's covered.

Sure.

And then um patients will have a very sort of straight line path to be from diagnosis to getting the device uh personalized for them to getting the device in their homes. And you're right, they can do it anywhere, right? They can they don't have to go to the hospital, they don't have to go to a clinic.

That's great.

If they travel, they can take the device with I have one here. You can, you know, you can, it really makes life um it it it it sort of bends to their life more than asking them to bend their life to a therapy.

That's amazing. Uh well, good luck. Uh you raised some money. How much did you raise and what does it allow you to do?

Yeah, so we ra we overs subscribed around. Look at that. We love it. The gunk. Uh we over the round to 100,000.

That's right. uh not not an easy time to raise money in the life sciences especially when you're doing something completely sort of non you know unconventional.

Yeah.

Um and you know that was it was a really interesting time right because

as as investors got more conservative they didn't want to operate outside their thesis and we're we're not a traditional biotech we're not a traditional medtech right so we really had to find investors that weren't looking at it from the modality in but were looking at it from kind of the disease state out. Um but it allows us to now sort of downshift. But we are um you know going to continue on you know get the hope read out get to the regulators and then start the commercial work

and really try to you know meet that urgency in the market and we're doing it with in partnership with big academic

medical centers that going to help us learn you know how do you identify the patients how do you get the therapy to patients yeah

how do you help them adopt it and adhere to the therapy and then how can we explore new new indications

that's amazing super exciting my my uh grandfather my late grandfather uh suffered from Alzheimer's and I remember he was doing the uh antibbody treatments but I just remember the frustration of waiting for those treatments and then kind of waiting to see what kind of uh impact that they would have and and just he was fully willing and excited to do whatever it took

and not having something outside of you know kind of more basic everyday health stuff uh to do uh was, you know, deeply frustrating. So, very, very excited that you're building this and uh come back on as you make more progress and congrats to the whole team on the milestone.

Thanks, man. I really appreciate it. I mean, it it is I say to people all the time, I I got the best gig in the world, right? Because I get to see this really interesting science get delivered to families that need it desperately. And and as much as I'd love for your story to be, you know, unique and it's unique for you guys, there's not a day that I don't run into people that say, you know, my mom or my dad or my aunt or my uncle or and so it's just it's just such a desperate need. I can't I'm so I'm so fortunate to be the guy that gets to kind of steward this. So I appreciate you guys giving us an opportunity to talk about it and share,

you know, the work that we're doing.

Yeah. Thank you.

Last couple questions from the chat. Ryan in the chat says, "Suspected effect size if successful. How many COG points are you aiming for? I don't

Yeah, I'll give you Yes, it's it's a it's measure for for me. And then

what what we're trying to measure is, you know, how much can we preserve cognition and how much can we preserve function, right? So, think of cognition as like memory and think of function as agency and independence. And so in our uh feasibility study, which was a study we did just before this one, we showed an almost 77% preservation of function and a 76% preservation of cognition. And th those numbers are best in class by a long ways. And so um if we in the big study show something similar to that or even a little bit less than that it it is it will be you know the most significant clinical impact in addition to we've never had an adverse event related to the therapy

and you know it's noninvasive and patient could use it in their home. So um that you know that's kind of how we're thinking about the impact and then we'll support that through biomarkers and all the stuff that you show in these studies that that you're making an actual you're actually making a difference.

That's great. Well, thank you so much for coming. Great to meet you. Look forward to

love what you guys are doing. It's such a cool It's such a cool scene. So, uh and and welcome. Looking forward to coming back and talking to you guys about the work that we're doing.

Yeah, we'll talk to you soon.

Thanks so much, Christian. Goodbye.

Thanks, guys.

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