Lisa Ricciardi, President and CEO of Cognition Therapeutics, was recently a guest on Benzinga's All-Access.
Cognition Therapeutics is a neuroscience company that is developing oral medications to treat neurodegenerative disorders, with recent breakthroughs in the treatment of dementia with Lewy bodies (DLB) and Alzheimer's disease.
Ms. Ricciardi was on the program to discuss exciting developments coming in 2025.
Cognition Therapeutics is a neuroscience company that is developing oral medications to treat neurodegenerative disorders, with recent breakthroughs in the treatment of dementia with Lewy bodies (DLB) and Alzheimer's disease.
Ms. Ricciardi was on the program to discuss exciting developments coming in 2025.
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NewsTranscript
00:00And it is my distinct pleasure to welcome in the CEO of Cognition Therapeutics, Lisa Ricciardi.
00:09It's fantastic to be here today, Lisa.
00:11Dan, thank you.
00:12I love your energy.
00:13What a way to start.
00:15Too kind.
00:15And as Roy said, I was the inventor of April Fool's Prank.
00:18So everyone, you can blame me.
00:20Lisa, let's start with this.
00:21Give us an overview of your company and a recap of the data from those two trials that
00:26Cognition reported in 2024.
00:27Happy to.
00:28So Cognition Therapeutics focuses on neurodegenerative diseases.
00:32We started this company, a scientist, neuroscientist, and a chemist.
00:36And they said, what is it that we can do to protect neurons from Alzheimer's disease?
00:41Fast forward five phase two trials later, here we have two great studies that read out.
00:48Let me add, we've raised close to $200 million in non-dilutive funding, Dan.
00:53And I always say to investors, you want to know what lean looks like, come talk to us.
00:58We have 25 people, seven PhDs, MDs.
01:01This is a tiny organization that are delivering the goods here.
01:06The trials that read out, the most recent one is called Shimmer, and it's in Lewy body
01:11dementia.
01:11And for people who don't know, it is such a complicated condition.
01:16The first thing you see are behavioral problems or disorders, hallucinations, aggressions, delusions,
01:23things of this nature.
01:24And the caregivers, you know, our doctors will say to us, a little 85-year-old woman comes
01:29in with her 85-year-old husband.
01:32She can't take care of an aggressive person who's having delusions.
01:36So that's the first thing.
01:38Cognitive problems, very significant motor function.
01:42These patients fall a lot.
01:44They're in the emergency room a lot.
01:45And then last, if you add that all up, people aren't able to really take care of themselves,
01:50dress, bathe, do these things, activities of daily living.
01:53So the results from our study, I have to say, were very, very positive and so encouraging.
02:0186% slowing of the behavioral psychiatric symptom, 86%.
02:08We also measured the caregivers.
02:10They were actually better at the end of the trial.
02:13The caregivers, because the person they were taking care of was obviously doing better.
02:1885% slowing of cognitive decline, 52% preservation and activities of daily living.
02:26So if you can dress, bathe, and shower, you might not be able to go to the grocery store
02:30and get back.
02:31These are meaningful changes.
02:33And then last, 62% preservation and movement.
02:37So honestly, we thought that was a home run.
02:40That's for Lewy body dementia.
02:43Briefly, in Alzheimer's disease, we read that study out over the summer.
02:46We refer to it as shine, mild to moderate disease.
02:49And our results were actually better than what we saw with monoclonal antibodies.
02:54We measure slowing of progression.
02:57So we slowed it by 39%, whereas ACI and Lilly drugs, 25%, 30%.
03:03As a reminder for the listeners, those are monoclonal antibodies.
03:08They're administered in an infusion center.
03:10And then patients need surveillance to look for brain bleeds.
03:14Our drug, once a day, oral, really simple.
03:18We, in October, had new data.
03:21And we looked at a group of patients in that study.
03:24It was all pre-specified.
03:25We weren't digging through the data looking for something good.
03:28It was pre-specified.
03:30They had 95% slowing of disease.
03:34Can you imagine?
03:35You have Alzheimer's disease.
03:36And for six months, no change.
03:39Incredible.
03:40We found these patients through a commercially available test, P-TAU-217.
03:45And so as we think about our phase three trial, we're thinking, how do we ensure that we get those patients in the study?
03:52So we're very pleased.
03:53We've been given great funding.
03:55And we feel like excellent trials were run.
03:57And look at the results.
03:59We're so excited about what we can do for patients in two pretty terrible conditions.
04:04Yeah, I mean, there are terrible conditions, Lisa, but those numbers are incredible and just amazing work you guys are doing.
04:10And to dive a little deeper, what are the similarities and differences between Alzheimer's and DLB?
04:16Great question.
04:17So one of the overlapping areas is in cognition, as it shows here.
04:23In Alzheimer's disease, that typically shows up first.
04:26People are confused, are not able to remember how to do things.
04:29It's not so much the case in DLB, but eventually these patients all have cognitive problems.
04:36The Lewy body patients are mostly known, as it indicates here, for some of the neuropsych challenges that they have, as well as the gait and falling kinds of things.
04:46The truth is the FDA knows a lot about Alzheimer's disease because there have been so many studies, not a lot of them successful, but lots of interaction.
04:54When it comes to Lewy body, we're all learning at the same time.
04:59And I would like to say cognition is a real front runner.
05:02Working with the FDA, working with key opinion leaders with the Lewy body dementia association, it's such a grassroots thing, Dan.
05:11You will see elderly people, like in the UK, 85-year-old people who are spearheading all of the awareness around Lewy body disease.
05:21It's really a grassroots, from the heart kind of effort because it's just not that well-known.
05:28And having a drug that works is going to change that.
05:32Yeah, that community and kind of, you know, just effort seems to really help things.
05:36And, you know, you've got to explain, DLB does seem quite different from what we think of other diseases, like Alzheimer's.
05:41Yes.
05:42Do you have to design a study differently for DLB, Lisa?
05:45Yeah, it's a great question.
05:47So when you look at these things that are on the screen here, they all have validated ways of measuring them.
05:53So, for example, under movement, we used a score.
05:56It's written there, UDPRS, validated, standardized instrument.
06:00All doctors who treat Parkinson's disease patients are familiar with it.
06:05Same thing for the activities of daily living.
06:07You see that in Alzheimer's trials as well.
06:10Cognition, there were probably a dozen things we measured.
06:13Again, validated.
06:15Same for the neuropsych.
06:16Like, we wanted to do a study with the kind of rigor that no matter who was looking at the results, they would say, right, that is how you measure the change in this symptom category.
06:27The amazing thing was to hit on all of them.
06:30But it is quite different from Alzheimer's disease.
06:33That's true.
06:34Sure.
06:34And, Lisa, you appear to have a drug that works in two different diseases as a small company.
06:39How do you move forward into phase three?
06:41Will you have to pick one indication?
06:43Or are you planning to develop the drug for each?
06:45Yeah.
06:46No, great question.
06:47Thanks for asking that.
06:48Yes, we do have two bona fide indications.
06:51Right now, we're planning first to go to the FDA with our discussion around the end of phase two in Alzheimer's.
06:58Why are we doing that first?
06:59Because the study finished first last summer.
07:02Second, we'll go to the FDA and discuss DLB.
07:05We want to be prepared to run either of these trials, which is to say, have an approved protocol, and from there, endpoints we agree with the FDA.
07:15From there, we move on to how to fund it.
07:17Now, the truth is, Dan, we're in a pretty big partnering process right now, and it may be the case that a company that wants to work with us and that we want to work with says, oh, no, we're doing DLB first or we're doing Alzheimer's first.
07:31We're being prepared for both.
07:34And what are your plans to eventually bring Zerba Masin to market, including the business development process that you have in place right now?
07:41Oh, great.
07:41Great question.
07:44That's a good one, Lisa.
07:45You asked only the good ones.
07:47Excellent.
07:47Yes, we have a pretty robust business development process.
07:50Let me back up and say, when I took over this company with my chief medical officer, the two of us made it our mission.
07:56We talked all the time to the companies working in neuroscience year after year.
08:02We had a little study.
08:03We had a big study.
08:04We'd call them up and get in front of them.
08:06And the whole point of that was for us to know their teams and for them to know the quality and rigor in this little tiny company.
08:14When you're a big pharmaceutical company, you look at us and you're like, who are those guys again?
08:18Those are the guys that do excellent studies.
08:21And you know what?
08:22It was so valuable because now we're able to move very quickly through discussion.
08:27So that's what we're doing.
08:29Certainly a CEO, I cannot guarantee we're going to find a partner, secure a deal.
08:33I'll tell you what, I'm working very hard with my team to ensure that happens.
08:38We anticipate if we're able to sign a deal, there'll be a good amount of non-dilutive funding that might allow us to raise capital in the markets because people see that investor fall back for us.
08:52And from there off to the races with phase three.
08:55Now, once all that is secure, we've gotten to the FDA, we have a partner, we have funding.
09:00And then we can talk about what you also asked, which is how do we commercialize this drug?
09:05All of that work begins well before launch.
09:08But we're not there yet.
09:10Thinking about it, but first things first.
09:12Of course.
09:13Got to take it one step at a time at very exciting times ahead, as it seems for you guys at Cognition.
09:17Can you tell us about your Q4 results?
09:19What does your balance sheet look like right now?
09:21Yeah.
09:21Yeah.
09:21We announced Q4 results a couple of weeks ago.
09:23We have $25 million in cash that takes us to the fourth quarter of this year.
09:28In addition, a non-balance sheet item is grant funding.
09:31I mentioned we've had close to $200 million of funding.
09:35So we have a $50 balance that is available to us to finish our trial called START.
09:41And that's for patients that have early stage Alzheimer's disease.
09:45We funded all of our trials with grant funding.
09:48And again, how does a little company that's raised, frankly, the modest amounts of money we've raised do five trials?
09:55That's how you do it with those kinds of supportive grants.
09:58So $50 million for that, $25 million in cash.
10:01You know, that's what we have right now.
10:04Clearly, we need more to run phase three, but we are thinking about how to do that.
10:09Of course.
10:09And listen, you've gotten me very excited.
10:11But why should investors be excited by Cognition in 2025?
10:15Great question.
10:16Again, you only ask the good ones.
10:18What we are thinking about is the following.
10:21We have some great catalysts.
10:22Get to the FDA to talk about what does end of phase two look like?
10:27What is the study?
10:28How big?
10:29Where is it going to be conducted?
10:31U.S. international?
10:33How many doses?
10:34These are things we feel like investors and strategic partners really want to understand.
10:39So two very important catalysts in Alzheimer's and in Lewy body dementia.
10:44Another critical catalyst is our ability, if and when we get there, to announce a partnership,
10:50non-dilutive funding, maybe other sources of funding at that time.
10:54In the near term, I'd say over the next six months, we have really important things that will change the direction of this company.
11:02And what I really want, Dan, is for investors to look at Cognition and say,
11:07God, that's a $12 stock or whatever they say, that they see the value in the work we do and in the excellent results we've generated and the top quality approach we have to clinical research.
11:20There's so much here.
11:21I want everyone else to see it.
11:24So beautifully said.
11:26Lisa, it was an absolute pleasure talking with you today.
11:28Thank you so much for your time and other of the best going forward.
11:31Thank you so much.
11:32Pleasure to be here.
11:33Thanks a lot.