Dr. Ann Childress and Shane Schaffer, Chairman & CEO of Cingulate, were recently guests on Benzinga's All Access.
Cingulate is a biotechnology company developing drugs for a range of underserved conditions. The company has developed a proprietary technology called Precision Timed Release™ (PTR™). The technology allows a single pill to contain multiple doses of a drug, relieving the pill burden many people with chronic conditions suffer.
Cingulate was just given clearance by the FDA to seek full approval for its lead candidate, CTx-1301.
Cingulate is a biotechnology company developing drugs for a range of underserved conditions. The company has developed a proprietary technology called Precision Timed Release™ (PTR™). The technology allows a single pill to contain multiple doses of a drug, relieving the pill burden many people with chronic conditions suffer.
Cingulate was just given clearance by the FDA to seek full approval for its lead candidate, CTx-1301.
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NewsTranscript
00:00Good morning, welcome both of you to the show.
00:07Good to see you, how are you today?
00:09I'm doing great Dr. Ann, it's not it's you know I think it's your first time for talking
00:13to me I believe.
00:14First time with you but yeah Ann's a pro now, this is her second time here with Benzinga.
00:19Well there you go, I'm excited to see what type of conversations we have.
00:23But Shane why don't you go ahead and kind of start things off for the folks that might
00:26not be familiar at home, give us a quick insight on what is it that your company does.
00:29Sure, so Cingulate is a we're a biotech company and simply what we do is we take products
00:35that have currently been developed by other pharmaceutical companies, your Pfizer's, Novartis's,
00:40your Sanofi's, etc.
00:42Some major products that unfortunately didn't do the exact optimization of their asset so
00:48that patients with various therapeutic ailments are getting the best possible outcome that
00:53they need.
00:54We have the ability to take in a single tablet one, two, three, four of the same or different
01:00medications and at the end of the day we put it into this little tablet and then we precisely
01:05time, style, ratio and then exactly the right time deliver when that medication gets introduced
01:11into the body.
01:13We have three lead assets right now, our first two products which which Dr. Childress is
01:17one of the preeminent experts in the world on so I'll let her do most of the talking
01:21here shortly is attention deficit hyperactivity disorder ADHD for short.
01:26So we have two assets in development there Dr. Childress has been our principal and primary
01:29investigator on those as great clinical experience with the product.
01:33Our third asset is an anxiety it's a product that is not a benzodiazepine but it's one
01:38that again what we're really focusing on doing is not just making it easier for patients
01:42to get a medication and just doing it one day that's important but let's make the outcome
01:47for the patient better.
01:48Let's make the outcome for providers like Dr. Childress easier to attain and let's make
01:53it better for payers as well so these products are reimbursed.
01:56Let's make life optimized and better that's what Cingulet does.
01:59Dr. Justin Marchegiani Now Dr. Childress ADHD is something that I've kind of had to deal
02:03with as well right so I went to remember I was struggling always in middle school high
02:06school and college I finally said you know what I'm paying a lot of money for these classes
02:10I've got to get it together and I finally went ahead and got the proper help that I
02:13needed but now you've kind of got folks that you know there's a shortage I would say when
02:17it comes to getting help for folks that deal with it as well there are a lot of questions
02:21I'm throwing at you but just talk to me about why this is such an important thing that you're
02:25doing that Cingulet is doing when it comes to ADHD.
02:28Dr. Chandrasekhara Well I've been working with Shane for about 20 years and 20 years
02:32ago we had a product called Focalin XR that I was working with with Novartis and it's
02:37a good medicine but it just didn't last long enough and we kept saying we need something
02:42we need this compound to last longer and so the next thing I know Shane has left Novartis
02:51and he starts his own company with some other folks that I worked with and they have a medication
02:58that they think okay we think this is gonna last longer so hey and will you do a laboratory
03:03classroom study that's where people come in they're on an optimal dose of their medication
03:09half are on placebo half are on medication placebo doesn't have any active medicine in
03:13it and then they take math tests at different points during the day so we can see when their
03:18medicine starts working when it it's at its peak and when it wears off based on how many
03:24math problems they're doing and at every time point we looked at with CTX 1301 from 30 minutes
03:33out all the way to 16 hours they were doing more math problems on medication than they
03:39were on baseline.
03:40Yeah.
03:41Give me give me more insight on the data from the phase 3 trial that you were the lead investigator
03:48on.
03:49Okay so doing more math, math is just a proxy for attention and focus right when you were
03:54when you were in college taking those classes you know focusing is hard right especially
04:01when you get to college and there's a lot of stuff in college that's kind of boring
04:05right and things that are really boring and it's harder for people with ADHD to focus
04:10on.
04:11Well one of the problems that we have with adults is that their day doesn't last eight
04:16hours when they come in and start working and then they leave work right it doesn't
04:22last 14 hours it lasts their whole waking day and ADHD doesn't go away when the clock
04:32hits five or when they get their kids from school or when dinner is done ADHD is still
04:37there and you know if I take my glasses off I'm not gonna be able to see you as a matter
04:41of fact I'm holding them in my hands because I won't be able to find them.
04:45My vision doesn't go away anytime right so I need something to help control it when I'm
04:52awake otherwise I'm gonna be falling and breaking things and and doing all sorts of horrible
04:57things so ADHD 24 7 365 disorder.
05:03Now we looked at math tests but the other thing we looked at was we looked at ADHD ratings
05:10ADHD symptoms and that looks at hyperactivity as well as inattention and I was blown away
05:17when Shane showed me our data I'm like good for me but even better good for your job right
05:24because we had people they started out what they started out around a 30 31 right symptoms
05:32right and higher is worse on this rating scale you can have all the way up to a 54 if you've
05:36got a 54 for total inattention plus hyperactivity symptoms you are in a world of hurt with your
05:45ADHD you're gonna have a lot of impairment anyway they started out about a little over
05:5030 and by the time they got to optimize dosing everybody got medicine we increased it to
05:58just the right dose with their tolerability and how well their ADHD symptoms were doing
06:04and they came down to about a 16 so that's really good right yeah well then half the
06:10people stopped medication and half the people continued on so we could do our laboratory
06:16classroom day at the end of that week the people that were on CTX 1301 they went from
06:24a 16 to an 18 still good still really great the people that weren't on drug went all the
06:31way up to a 30 again so to give you an idea of what does an 18 mean on the scales for
06:36you for your viewers well an 18 really is remission that's what we consider remission
06:42of ADHD symptoms so our entire active day which sorry guys love it it's just we're not
06:49the other drugs stopped measuring eight or six or ten or twelve hours you said look let's
06:53just look at their day and the day is what the day is like Dr. Chodos said take your
06:57glasses off you can't see your ADHD symptoms are still there and tonight you said one really
07:02important thing and what Dr. Chodos is perspective on this you know there is a shortage out there
07:07there's a lot of issues around that but we bring three doses precisely time precisely
07:13ratioed in one tablet that reduces the number of scripts out there the number of medications
07:18that doctors and pharmacists have to write and fill and we do it in one simple tablet
07:23that is going to be reimbursed on market access so how does that change your life and your
07:27Oh my gosh okay well I can talk just the shortage has been making me crazy right because
07:33you have to send things to this pharmacy in that pharmacy and the pharmacies won't tell
07:37the patients until they're actually there and you send a script it's it's a whole thing
07:41but one of the other problems is not only do I have to deal with one prescription with
07:46the shortage in a month I may have to deal with two prescriptions because somebody's
07:50taking an extended release medication and then they need a booster at the end of the
07:55day I just had a 15 year old who came in yesterday and he failed geometry right so
08:01he's taking his methylphenidate and in the afternoon dad is having to help him with his
08:08homework well by about four o'clock his medication is gone so now they have to take a booster
08:12in the afternoon and they have to time that just right to make sure that it kicks in and
08:19it's going to work when they can do their homework otherwise and it won't keep them
08:24up at night because then the next day it just has a lasting effect and that's where
08:28you know I kind of struggled with it as well it's like hey I got a time this perfectly
08:31so that I'm not falling asleep at 6 o'clock when I have a 9 o'clock interview for a big
08:35job right so yeah I love you saying that that's one of the things we did is when we started
08:41cingulate it was dr. Brahm Silva and I was sort of the three co-founders and and loved
08:46it known in for so many years we said hey let's ask and let's ask the experts let's
08:51bring everyone in and Jeff Newcorn in how do you want to develop this drug if we're
08:54going to build the ideal stimulant how should we do it they told us how to do it we listened
09:00and we built it so we will deliver a full dose at eight hours we wait seven hours later
09:04so we're going to an F yeah to 2.30 in the afternoon we're gonna give you 20% stop the
09:09crash stop the rebound stop the wear off just give you a little bit of dose to get you into
09:14the early evening breakfast to dinner home to homework rubber with the taps yeah children
09:19to adults we can cover that entire spectrum. Howard. Yeah well Shane I've got a final question
09:23for you but dr. Childress any final thoughts for me before I move on to Shane.
09:27Shane. Okay I have to tell you one story for a patient I actually sent Shane a copy she
09:32wrote me she actually sent me a card because she got diagnosed for the study and she basically
09:37said you've changed my life okay this medicine changed my life she was struggling trying
09:46to get her associates degree in college not doing very well she started this medicine
09:52that was her cohort started in January and she had a 4-0 that semester we changed your
09:59life Shane you're amazing. Dr. Childress Well Shane let's kind of get yeah and we appreciate
10:07you and Shane I'm gonna kind of get to you in the final question of you know there are
10:10a lot of things that folks are looking forward to in terms of the pipeline and what is coming
10:14up next especially for the second half of the year you've got comments in the chat as
10:18well in terms of hey we were looking forward to whether it's different types of partnerships
10:21whether it's the financial health of the company whether it's the things in the pipeline our
10:24viewers kind of want to know more insights on what is yet to come that you have said
10:28hey was the plan for 2024 where are we in kind of meeting those milestones that you're
10:33kind of working towards. Shane. Exactly thanks for that question so I mean number one we've
10:37just in the last month really introduced some very positive news to the to the street and
10:43letting them know that number one the FDA has cleared our lead asset to be submitted
10:48for its with its new drug application. We're on track to do that in the first half of next
10:52year the variable there is is what how long of stability data will the FDA accept. So
10:58we could get it out in January it could be June's but that there you have a six-month
11:01gap there then this product is on the clock and we know yet the track record of stimulants
11:07is a very high level of approval they're very safe they're very effective and the data that
11:12our products has shown and Dr. Chodos has generated is something we cannot wait to demonstrate
11:16and show to the FDA and thought leaders across the country. In addition to that our anxiety
11:22asset is poised to begin development work next year as well. This is a product again
11:27that we're going to deliver three doses of a product called buspirone at the right time
11:31right ratio and right style. You know anxiety is a major issue it's a number one issue in
11:35America right now and here's an asset a product that can help millions of patients lives.
11:41So that's coming down the pipeline as well we have our second ADHD asset there's an asset
11:45in insomnia there's one a major depressive disorder. This platform has so much applicability
11:51that just we can go on and on and on but to your listeners and I should say viewers what's
11:57really important is what is our financial health you know we're raising capital we always
12:00have to. Wade in our humble opinion we are tremendously undervalued ADHD is a 23 billion
12:07dollar category and I believe our asset is very well designed for most patients in ADHD
12:14don't expect to get a 50% market share but I think we're really well designed to really
12:19capture a great deal of that. There are partners we're speaking with to either help us commercialize
12:24or fully commercialize the asset on their own. Those negotiations are underway. Second
12:30to that is we already have a commercialization strategy in place. We have the paperwork signed
12:35the agreement is there it's with Indigene. Indigene just went public about a month ago
12:40they're a multi-billion dollar company and they are basically a soup to nuts go-to-market
12:45company they have sales reps medical liaisons medical information market access everything
12:51you need to launch we can bolt on to. Here's the advantage to our shareholders we embrace
12:55this philosophy every dollar we make is a dollar our shareholders get versus us sharing
13:01it with some other pharma company and you know big pharma is not knocking on the doors
13:05of ADHD anymore they're just not. You have a lot of smaller players like singlet there
13:10was a day like Dr. Ann was saying you know Novartis Shire and you know yeah big companies
13:14are out there J&J that's not the status anymore. So we have a lot of products in our pipeline
13:20our financial you know health is good we continue to raise money as economically as possible
13:25and do that and if the shareholders of BS.
13:28The last question for me you mentioned that you're you know in your humble opinion you're
13:31massively undervalued you have folks talking about hey why should we buy now right so I
13:36guess the question to you let me spin it a little bit differently is and I promise it
13:39will be the last one what is the market getting wrong what are they missing hence you feel
13:43like you are undervalued at the moment.
13:47I think that's two things you know you know number one is they don't see how our product
13:51is going to fit into an ADHD category knowing that the last 10 products that have all been
13:56developed and launched failed. Now I'm going to say fail they didn't fail clinically they
14:01failed commercially and you go back to the four key elements of this onset duration booster
14:07dosings that required and then what is the is a rebound crash or tolerability issues.
14:13The last set of products didn't really address all four of them they might have addressed
14:17one let's call it swallow ability are they addressed let's focus on early morning or
14:22let's focus on making a drug last all day long 24-36 hours yeah we didn't focus on all
14:27four of those characteristics and look Wall Street needs to understand that you know investors
14:31need to understand that we've accomplished this our data demonstrates this yeah we show
14:36this unprecedented data with effect size which basically means real-world evidence that's
14:41you know that's that's really a piece one so they look at the old ADHD products the
14:45newer ones and they go how these guys going to get it.
14:47The flip side too is there's a lot of value in a licensing partnership I get that around
14:52I get the value there we are prepared to go into those we were having those negotiations
14:57now but on the flip side too we're prepared to commercially launches on our own with a
15:02major partner that's there as well and we pay on a fee-for-service basis and we're prepared
15:07to launch this the market access which again we'll be talking about very soon this product
15:12is going to get reimbursed because of its major clinical benefits one drug versus two
15:16or three better if you know it just works across the board those are the things that
15:20I believe the street is really missing and and that's why again I want to thank Dr. Chodas
15:24because you know hearing from experts like Dr. Chodas and others is what really I think
15:28resonates stronger than the you know me yeah around this you know the farmer guy right.
15:34I know the last time you and I talked you had a big investor in the company that you
15:37guys kind of had a conversation with us Dr. Chodas I appreciate you coming in as lead
15:41investigator on things as well and I know you mentioned hey you've got some possible
15:43announcements when those deals strike when those milestones are achieved I'd love for
15:48you to come back on the day that you talk you know release that news so we can get the
15:51audience the questions that they want to hear but thank you both so much for your time I
15:54really appreciate it.
15:55Thank you.