#1241 Mannkind CEO Talks Afrezza

July 1, 2024Scott Benner

Today we are discussing Afrezza with Michael Castagna, CEO of MannKind.

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Scott Benner 0:00
Hello friends, welcome to episode 1241 of the Juicebox Podcast.

Today, my guest is Mike Castanea. He is the CEO of the MannKind Corporation better known to you perhaps as the people who make the inhaled insulin a Frezza. Please don't forget that nothing you hear on the Juicebox Podcast should be considered advice, medical or otherwise, always consult a physician before making any changes to your health care plan or becoming bold with insulin. You can help support type one diabetes research right from your phone right there at home by going to T one D exchange.org/juicebox. and completing the survey join the registry complete the survey the whole thing should take him out 10 minutes and the answers to your simple questions will become part of how things move forward T one D exchange.org/juicebox. The T Wendy exchange is looking for people with type one diabetes and caregivers of people with type one who are US residents. When you place your first order for ag one with my link, you'll get five free travel packs and a free year supply of vitamin D. Drink ag one.com/juice box want to save 30% off your entire order at cozy earth.com It's as easy as using the offer code juice box at checkout. This episode of The Juicebox Podcast is sponsored by ever since the ever since CGM is more convenient requiring only one sensor every six months. It offers more flexibility with its easy on Easy Off smart transmitter and allows you to take a break when needed. Ever since cgm.com/juice box. This episode of The Juicebox Podcast is sponsored by us med U S med.com/juice box or call 888721151 for us med is where my daughter gets her diabetes supplies from and you could to use the link or number to get your free benefit check and get started today with us med this show is sponsored today by the glucagon that my daughter carries. G voc hypo Penn Find out more at G voc glucagon.com. Forward slash Juicebox

Michael Castagna 2:28
Podcast got my Castanea the CEO of mankind Corporation.

Scott Benner 2:32
Mike, we have we've been trying to do this for like two years it feels like

Michael Castagna 2:37
it feels like and maybe longer because of COVID The time has just flown by Yeah,

Scott Benner 2:41
really interesting. People always say to me like what are you gonna have someone from mankind on? I was like, I'm trying. Like I'm trying to do my best. I guess you're here today. I'm going to ask you questions about about the inhaled insulin, the Frezza. Am I saying it right? I Frezza? Because you got it right. Nice, okay. And I'm going to kind of pick through how we got to where we are now what your goals are for the future, that kind of thing. So has the patent been sold? Like did this start out at a different company? What's the lineage of it?

Michael Castagna 3:10
Yeah, no, great, great question. never a better time to talk with us. As we get ready for new data coming out here very shortly, your listeners will be even more interested in healthy and inhaled insulin. As we go forward, the technology goes back to 1991. So actually 33 years. And there was several companies that are founder after the man owned, and he was investing in inhaled insulin back in the late 90s. Mainly because he was working on mini med the insulin pump as many your listeners are really familiar with Medtronic. And he realized that the major problem was the input of the insulin. And the everything we're trying to do is manipulate that profile the insulin to increase your ability to control your sugars. But but it was very hard to have that passed on set that he was looking for as an engineer and a physicist, he kind of knew the mechanics and engineering before any of us can even see what CGM look like he had that figured out in the late 90s. When he sold many meds Medtronic, he then stood out to build mankind in 2001 to three of his companies combined them and made mankind. And so the technology has always been within. And we've patented over 1200 patents at this point. And the company has continued to progress since 2001. Till today. And it took I always remind people and they asked me like, why are drugs so expensive. And think about insulin as 100 year old product, it took us 20 years 75 trials and $3 billion to take on your your old product and change route of administration. And you got to think about you know, that's shouldn't be that hard. It shouldn't take that long. But that's how long it took just to bring this innovation to patients. And the good news is, it'll be here for the next 20 to 40 years that I can see. And so we're we're just getting started. I hate to say that because as you know, this product has been around for a while, but we had to redo a lot of the data. And we'll talk about that today. What we're doing now and what's coming.

Scott Benner 4:55
Yeah, I mean, it's interesting because as a layperson when this first popped up in you know this like ice then people are like there's an inhaled insulin. Are you going to let because people look to me, which I don't even know how I got in this position sometimes Mike but like, you know, they looked at me like are you gonna let your daughter use this? And I said, Well, top of my head, I'm going to avoid her inhaling something if I can, only because I don't understand what comes next. And so, I mean, obviously if there's that much money and that much time being put into it, you don't have those concerns, or I'm assuming you diversify somehow. So why? Why shouldn't I be concerned about it?

Michael Castagna 5:32
Yeah, I mean, just use some color, I take the product personally, my family takes it, we're we wouldn't take something we didn't believe or have competence in. Right. And so that could just some confidence that could mean we're not that smart. But I think we're pretty smart. You know, when you when you study drug development, right, you're always looking for toxicities. And so by the time you get FDA approval, you've been through the wringer in trying to show that it's safe and effective, sort of that safety profile was established many, many years ago throughout all the clinical trials. And then people say, Well, this is a lifelong treatment. How do I know when you think about inhaled insulin? You know, in our particular technology case, we bind human insulin, water, and a particle called FTK P. And what happens is when your lot when the particle touches your lung, it releases the insulin directly into your blood. And the FTAAP gets excreted. So think about a car, taking passengers and delivering them and then leaving the FTK P doesn't metabolize doesn't do anything in your body. So what you're really taken as the human, it's on the water. And we know your body likes human insulin, and we know the shows in your body as well. It's not an analog insulin, it's not a modified insulin like Lantis or something like that. And that's what people miss. They think they're putting a novel target in their lungs, and is that going to be safe and effective? And obviously, safety's number one. And so we've studied this and over almost 3000 patients and their long term lung safety study was two years. We've done a lot of trials for six and 12 months at a time. And now we're going into kids. And so that was one of the obviously questions that we asked the FDA is are you comfortable with us going into children, and they were so we started that journey six years ago. And that trial be reading out later this year.

Scott Benner 7:14
So that is that the inhale three study. That's

Michael Castagna 7:17
the inhale one study. So inhale, one was children. And then inhale three was one I funded because I believe the number one alternative choice that people go to his insulin pumps, and we didn't have a lot of data head to head on insulin pumps. And so we wanted to do a bigger study showing usual care which would include insulin pumps or MDI.

Scott Benner 7:35
Ultimately our injection helped me understand the the process. The FDA in the United States, they lean a little more into being aggressive letting people decide what they want to use, but then they'll kind of tack a post marketing study on to you if they think it needs more looking now like the EMA, UK that kind of stuff over there in the EU. What did they say to you like how come you don't have approval in the UK for example? Yeah,

Michael Castagna 7:59
they never said no to us just to be clear, we never filed you know, okay. And so at that time, if you

Scott Benner 8:07
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Michael Castagna 9:19
When the company launched Pfizer, Sanofi was supposed to file internationally. And when they handed the product back to us, those filings were all stopped. And then mankind honestly was almost out of money. And Helen's almost disappeared, went bankrupt. And so we just didn't have the money to file around the world. We did file in Brazil, we have filed in India, we got approval in Brazil, we're expecting approval momentarily in India. And we know in Europe, they're going to want pediatric data. And so that was one of the things we are waiting for extraordinary funding and pediatric study. And it takes takes about two years to get a drug approved from the time you file and you're better off trying to get one package up front in Europe or Canada or some of these markets because the poor pricing is determined at launch. And so once you launch, if you don't have a full data package or full expectations, you may not be able to have the right price point. And then you're stuck with that. And you may not be able to launch and commercialize the product. And that's really what the holdup has been in Europe is we wanted to get the enail three data show and head to head against insulin pumps. We wanted to get the pediatric study done to show that we can have an expanded population. And we want it to look we're also looking at some other some other areas we'll we'll talk about but but that total package for you're also with the economic analysis will be really important for Europe. And that's really what we're waiting on. So that's, that's coming.

Scott Benner 10:36
Tell me more about how close did the company come to not existing anymore?

Michael Castagna 10:41
For weeks, by really twice? Yeah. When I became CEO, we had less than we were burning about 24 million a quarter to stay alive. And we had about 20 million in the bank. And so I first joined the company, we really were at the same point in 16. And then again in 17. And then at one point, COVID-19, I can remember exactly or fortunately, but we were four weeks away. He was 2018. Actually, we were signing a deal. And it was a rumor I was going we were going bankrupt and everyone's getting fired. And it wasn't true. We were about to announce a major deal. And we were holding out for that pemilik motors get the paperwork done. Now the company has been public company for 20 years, which is good and bad. It gave us the capital to bring innovation to market. But it was also brought evil side of bias. They've been a public company and people that make money by trying to make companies think. So that was a it was a love hate relationship. But I think today we've built good shareholder return over the last seven, eight years and things are going in the right direction. People

Scott Benner 11:38
would never think about that. Right? Most people wouldn't consider that somebody would try to short your stock to make money or something like that. And you're you're better off trying to make insulin and this is all happening. What made you take the job? Where did you come from before mankind?

Michael Castagna 11:51
Yeah, so I'm a pharmacist by training, I chose to want to build a career in the pharmaceutical industry because I thought I can make the biggest difference in the world by doing that versus working in a hospital or running a pharmacy chain. And I feel very good about that choice. And I look back in my career I worked in HIV and helped build the one pill once a day regimen I worked in fertility I worked in rheumatoid arthritis biosimilars growth hormone, and number and growth hormone trying to get a parent to inject their kid, just once a day for three, four years was a nightmare. And I think about now diabetes and insulin, you know, trying to inject them three to five times a day or a pump is equally as difficult when you first go down there life depends on you. And that to me is very stressful just thinking about it. Sitting around Bristol Myers, Novartis came out to California for Amgen. And I was very happy at Amgen. And then when I was a shareholder, mankind until it got approved. And then once I got approved, I sold my stock. And then about a year and a half later, I see I do turn around. That's kind of what I specialize in. It was 20 years. And I saw that inhaled insulin came back from Sanofi and it was in Valencia, California, not being from California, I didn't know where Valencia was. So I had to do a Google search. And there was an hour hour and a half for me. I emailed the CEO and said, Hey, I would love to help you turn this around. I've seen the patient profiles online, I've seen what this drug can do for people to make a difference in their life. And for me, that's what life is about. It's about how do you make someone want to happier everyday? How do you make a tremendous difference in their life. And I actually did not. Some people know this, but I didn't want to work in diabetes, because my father, I didn't know him growing up. By the time I found out who he was, he had passed away from complications of diabetes. So for me, I didn't want to work in a disease every day that I thought about I missed out on this person my life. Yeah, unless I thought I can make a difference. And that's when I saw inhaled insulin is that time Dexcom was barely popular in 2016. But I see these people these incredible time and range profiles and flatlines. And I was like, What are they doing? And how are they doing it? And that's really what convinced me that mankind was something worth taking. And so long story short, how man was supposed to meet him, our founder, and he had passed away on February 25 2016. And the only reason I remember is this my daughter's birthday. And had he not died that day, I probably wouldn't have stepped off the legend to take the risk. But you know, she's your kids are important to you. And that that was an important date. And he chose the day he died. He went and one more wedding anniversary with his wife, I was told. And that was it. He was 91 years old, do everything he could and and he had a great life and did a lot for society.

Scott Benner 14:22
So you said some people in your family use a Frezza? Who

Michael Castagna 14:26
I think for their privacy of your mind. I don't want to answer but I have a lot of family of 40 cousins and

Scott Benner 14:32
and there's type one there. type one and type two. Yeah, my dad,

Michael Castagna 14:35
my dad had seven children and he has lots of grandkids and some of them suffered in diabetes as well. I

Scott Benner 14:41
want to ask questions about using it but I want to get past the like I have listener questions here and they're gonna you know, they say, I hear some people say they have a persistent cough from it or they can't take it or that it hasn't been approved because of concerns about breathing issues or lung cancer. Like can you clear that up for me? Tell me everything you know about have that and then I want to hear about how it works and how people use it day to day. Sure. So

Michael Castagna 15:04
if you have asthma, or COPD, this is probably not the right product for you. Right. And that's because we did a study showing that a kid has me at a higher risk of bronchial spasm. And so we don't disagree with that conclusion. And that's about 10 20% of people in the world that the country that have that underlying disease, and so that's probably not the right product for them. In terms of a lung cancer, you know, you gotta remember there's been over by now 20 30,000 People took a president us there's a bunch of exuberance. So there were some imbalances in the trials of people who smoked, who develop lung cancer. And, you know, unfortunately, we smoke you probably more prone to lung cancer. But I don't think there's ever been a causation that inhale and some causes lung cancer. And so you know, when you study a drug in 4000 people, 3000 people, unfortunately, a subset of them will get cancer on them and other types of cancer, lung cancers, and that, you know, but that rate of cancer was no higher than the general population. That's remind people when you're studying drugs, and sick people, in general, you have side effects that come up, and you got to manage those. Also,

Scott Benner 16:05
the idea is, if you would have followed those people, most of them would have gotten the cancer they got to begin with, it's just you're grabbing a subsection of people and watching them closely. Is that right?

Michael Castagna 16:15
Right. And you're watching them closely, and FTS, is to go back and look in time and sway, go back and look for cancer. And so you found two more people post through trial that got cancer. And so but if you think about the product and the 30, some 1000 people have taken it, we have knock on wood, only had one additional lung cancer recorded, which was in a person who smoked for 40 Pack years, and took the drug for three months and amendments. So So I feel pretty good about the safety profile, the safety and surveillance we've done. I don't see an increased signal, we'll need to work with the FDA on that question. But I always say, you know, we know how sugars, cancer, we know how sugars cause peripheral neuropathy, retinopathy, kidney disease. And so for me, it's it's about avoiding the complications of diabetes and making sure you have really, really good control. And as we know, in this country, that control has not materially changed in 2030 years. So how do we keep giving people the best set of tools that work for them. But the safety profile, this product, I think, is pretty proven at this point after a decade on the market. It's not like it's novel. It's not like it's a new drug. It's human insulin that people take. Yeah, it

Scott Benner 17:24
feels like there's a, we're in a moment here. Because I feel like you're about to tell me that you've got some news about, you know, children and Impreza, I just interviewed a man this morning who had type one, since he was 50s 58. Two and a half years ago, his doctor on a kind of a whim put him on two and a half milligrams a week of Manjaro. And now he doesn't use insulin anymore. And that's not to say that Manjaro cured has type one diabetes, but he 1,000,000% has type one diabetes, got the auto antibodies there. And as I was talking to him, it just becomes abundantly clearly, we don't even know what that GLP completely does get, like, and how long is it gonna take to figure that out? You know what I mean? Like, you need to be interested, when you see stuff like that, you know, like, you need to say, I wonder where we could take this and I feel that way about a Frezza. I think people will say like, I mean, I've had probably, I don't know, maybe five, eight people on the show who have used it, or are users of it. But I see people online who are fervent, they are like, excited to tell people about it, you know, like, where's that excitement coming from like, so for a person who's accustomed to wearing a pump or injecting and they count their carbs and they cover their insulin, they get high? They correct. They get low, they eat some food, like when that's their day to day, like how does that change? If it does with a Frezza?

Michael Castagna 18:43
Well, I think you know, the good thing I can tell you is all the people you see online, all the stories out there are all self driven, meaning we can't pay for these stories. I had someone on Reddit kick one of our patients off saying, Oh, they can't be that good. I'm like, we don't pay people we can't, they'd have to disclose that that's illegal. And so I do want your listeners to first know and he still use the other mankind to not pay to get place they they generally are people sharing their public health, which is actually why I took the job because I saw this wonderful feedback loop in social media that I said, Well, that's amazing. How can I help bring that to life. And what those patients did is a few things that were different than our trials. One, one, they figured out appropriate dosing. And what I mean by that Scott is, you know, the company at the time was developing a product that was more one to one ratio in terms of how label doses to the conversion will be seen over time as patients up to titrate, up to about 1.5 to two times their injectable dose. And so that's the studies we're now doing to show that that increase those gives, you know, more hyperglycemia number one, an equal or better control number to do what you're doing today. So a lot of the new data you'll see coming out will be in that new dosage scheme coming out. Nada and future conferences. The other thing that people ask me like why, what do they feel differently? And then I'm one thing I get is I feel free and the question is, why do you feel free You don't realize how much stress you have on counting carbs, how off you are on the ratio of counting carbs, your insulin sensitivity ratio. People don't realize the temperature of your skin, the angle of injection, pump occlusion sites, you know, back content, we miscalculate all these things. Yeah, right. And they're not that accurate. And so I always joke and say you think you're giving one unit of insulin. But if you change the angle, the injection, it's point 5% off, if your temperature was hotter North pasture, there's all kinds of things that go into batch to batch variability than insulin also happens. When you think about a present, we fill every cartridge to the same, meaning every four unit is identical for units of insulin, there is no variability, because what happens if the batch comes out a little less, we follow the pattern a little bit more. So it's always the same where biologic when you're injecting, you can't change the volume of the biologic. And so every living batch of cells that you produce in biologics, in general, have some variability inherent in the cell organism, and you can't keep in that range. And that's not the case with the present. So you pretty much get this similar dose every single time. But there's all kinds of variability that a patient goes through. And the second part of that variability is timing. And so you're trying to guess the peak of insulin to your peak of food, and those just mismatch by an hour or so. And then the insulin is in your body for four to six hours, FTO. And yet, and so that's really what people you know, we've done enough studies now that I can confidently tell you, the time I Bolus, my insulin, whether it's a pump or a pen, it's generally peaking about 90 minutes later, and it's out my body four to six hours later. And this is why people say, Oh, I got snuck up on a low hyperglycemia is because we're trying to avoid those late and lows. And you're frustrated as a person living with diabetes, that, you know, your sugars aren't coming down, you're seeing them go 200 to 6300. And you're then given another Bolus, and then you're stacking your insulin and you're crashing two hours later. And that whole process is stressful and frustrating. And when you're out at dinner and drinks with your friends and family, you don't know you're gonna have one drink or two, you don't know if you have dessert or not. And that's all you're thinking about as you're talking to somebody. And in the case of a president, it changes that entire equation, reverses that meaning you're in control your sugar, because I inhale, when I eat, when my food shows up, I'm not guessing when my food minute show up, I'm not going to the bathroom to hide, I can inhale in two seconds. And that insulin is now working within five to 10 minutes. And so because it's inhaled what people it's called monomeric versus hexamer. And we make a Frezza. We bind it in an acidic form and monomeric form, which means soon as it goes into the lungs, and it disassociated from Fe KP, it goes right into the blood in its active form at your liver very quickly. And you can show when that's why you want to get the right dose up front, because you really suppress the liver, hepatic production in the liver. And people don't realize that that process when you take injectable insulin, breaks down about 45 minutes later, and then starts to hit the liver and then steps off the signal. And that's why injectable insulin just takes about 90 minutes to kick in. It's nobody's fault. Yeah. And so our patients aren't counting carbs. That's number one, you're taking a four, eight or 12. When you want to take more, you take more, and you could take it as soon as one hour. So if I was doing Hill, and I see my sugar set up to 200, you can take another four, eight within six minutes and bring that control into your range that you're trying to import. So how

Scott Benner 23:11
do they figure out like, the cartridge size that they want to use? Because one of my notes here is just it says dosing confusion. It says like I ask people who are successful with the Frezza how to dose they're like ah, you know, like sometimes I take a four and I take an eight like, like how is that? Like? How do you direct people where to where do they start to learn? I used to hate ordering my daughter's diabetes supplies, and never had a good experience. And it was frustrating. But it hasn't been that way for a while actually for about three years now because that's how long we've been using us med us med.com/juice box or call 888721151 for us med is the number one distributor for FreeStyle Libre systems nationwide. They are the number one specialty distributor for Omni pod dash. The number one fastest growing tandem distributor nationwide, the number one rated distributor index com customer satisfaction surveys. They have served over 1 million people with diabetes since 1996. They always provide 90 days worth of supplies and fast and free shipping. US med carries everything from insulin pumps and diabetes testing supplies to the latest CGM like the libre three and Dexcom G seven. They accept Medicare nationwide and over 800 private insurers. Find out why us med has an A plus rating with the Better Business Bureau at us med.com/juice box or just call them at 888-721-1514 get started right now. And you'll be getting your supplies the same way we do. This episode of The Juicebox Podcast is sponsored by the only six month where implantable CGM on the market, and it's very unique. So you go into an office, it's I've actually seen an insertion done online like a live one like, well, they recorded the entire videos less than eight minutes long and they're talking most of the time, the insertion took no time at all right? So you go into the office, they insert the sensor, now it's in there and working for six months, you go back six months later, they pop out that one put in another one, so two office visits a year to get really accurate and consistent CGM data that's neither here nor there for what I'm trying to say. So this thing's under your skin, right. And you then wear a transmitter over top of it, transmitters got this nice, gentle silicone adhesive that you change daily, so very little chance of having skin irritations. That's a plus. So you put the transmitter on it talks to your phone app tells you your blood sugar, your your alerts, your alarms, etc. But if you want to be discreet, for some reason, you take the transmitter off, just slip comes right off no, like, you know, not like peeling at or having to rub off it. He's just kind of pops right off the silicone stuff really cool. You'll say it. And now you're ready for your big day. Whatever that day is, it could be a prom, or a wedding or just a moment when you don't want something hanging on your arm. The ever sent CGM allows you to do that without wasting a sensor because you just take the transmitter off. And then when you're ready to use it again, you pop it back on, maybe you just want to take a shower without rocking a sensor with a bar of soap. Just remove the transmitter and put it back on when you're ready. Ever since cgm.com/juicebox, you really should check it out.

Michael Castagna 26:38
My doctor asked me the same time every time I get how much and LM can you use? And I said, Well, depends what you mean. It depends on if I have a big meal I take a lot. And if I don't I take a little. And he doesn't well, how do you know? And I said, Well, you kind of get to know the product. It's kind of one of those things like you know how to drive and are you going to 60 or 65 or something like you just learned through the process of experience. And what I tell people is if your sugar's at 200, right, you take a four and you're gonna see how much of four drops you know, think about a four is more like two units of injectable. And you know, tennis generally are going to drop you 160 points, which is where you'd be worried about. So a four unit cartridge, you're going to see does x maybe drops you 30 points, maybe jumps to 50 points. And just know if you're trying to bring your sugar's down, you know, a little bit more, you might take an eight and then see what that does to you. You know, I don't worry about what I eat. I was funny. One time we did an FDA commercial and FDA made us take out food in the commercial because they didn't they said people live in diabetes shouldn't be eating pizza or desserts. But our patients do often live their life and they do take their product. And yes, we don't condone that or endorse that behavior. But the reality is, it's about controlling your sugar, and us giving you the tools, whether it's our product and other products to do that. But I always tell people, you know, like, right now the studies we're doing to to your point, Scott, we're given the first dose in the office, because we give you a shake, and then we give you the president, because no one ever sees their sugars come down on the first hour. And all of a sudden, like, Oh, my God, am I gonna go low? Well, no, because it 40 minutes, 45 minutes, the President had a peak effect. within the first hour, even if you went from 190 to 90, you're pretty much you know where you're going to be at that point. Right. And so that's what people don't understand. Even unfortunately, the Dexcom arrows will still show double down, you're like, oh my god, I'm gonna go low. And I say just wait 35 to 45 minutes and see where you are. Now. Yeah, be safe, have something next if you need it. But the reality is just give yourself 30 to 45 minutes to see how the product works. And then, you know from there, you're going to learn within a couple of days. That's what we see within seven days when you live with type one diabetes. Unfortunately, your your doctor, you know exactly what your body does, you know how to respond to various foods. And you're going to see how this drug works relative to your own experience. The area, I'll give you some, for your listeners, I'm sure a lot of people do try this is a lot of people will use it on top of an insulin pump. And then they'll the Bolus are pumped and they're frustrated. And then they'll take a phrase on top of it, or present does its job it brings down your mealtime control. And then all of a sudden that pumped insulin kicks in two hours later and they go low and they want to blame the president and the reality is that Bolus just takes an hour and a half two hours that wasn't our fault. We did our job we cleared out your sugar your pump finally kicked in because you got tired of waiting for it. I just give people caution right we don't recommend using on top of a pump we know people do that. But that's some of the work that I see people often these tell me Mike price was too powerful. I need to tune a cartridge and I said you must be on an insulin pump. How'd you know because don't whoever asked me for two unit cartridges or didn't generally on insulin pumps. So

Scott Benner 29:30
are people so people generally speaking are shooting Basal insulin like Joseba or something like that. And then using a Frezza for meals were to break high blood sugars,

Michael Castagna 29:40
their meals full time meal meal tolerance. So I look at our population today and half of them have type one roughly and half of them have paid to make juice could be on GRPs basil doesn't matter. They're on all kinds of stuff right? And they add Frezza for their mealtime hives and so that's that's one population. And then that's like one population. I See it in our in our data a couple of different ways. We see some people use a Basal full time and present for meals. We see some people use it just for special occasions or stubborn highs. And we some see some people use their pump for their Basal modulation. And then if present on top, we don't have a lot of data on that third scenario of people just using it. Or on top of their pump, we have some studies we've done, but it's very limited data out there. And the data wasn't good or bad. It just showed it works. But don't show it any better than what you're doing.

Scott Benner 30:27
Yeah, would be interesting to see someone like on loop, for example, but not but not for boluses for meals, and then do that, that would probably be interesting to say, Yep, I found myself confused a second ago. So if if somebody's injecting or using a pump right now, and their insulin sensitivity is one unit moves them 50 carbs, then a two unit cartridges of a Frezza moves them how far our

Michael Castagna 30:53
trials that we're doing. Now there's a conversion table and label series taken zero to four, whatever you just the numbers you just came up came up with with, if that said, you're going to take three units of injectable insulin, our label would say change that to a four unit cartridge. If whatever ratio you just did came out the six units of injectable insulin, our label would say convert to an eight unit cartridge, we have the only comes in for age well. And you can add those up in any four unit combination of the 48. And so we've shown up the 48 units, it's linear. And you can add a two fours to stick to eights, two twelves. It doesn't matter. You pick whatever dose you're trying to get at. And it's a two second inhalation and doesn't you know, some people have like 30 seconds on the you don't need to do that. And some of the people may cough or say it's irritating me, you know, it's really a low you don't breathe really hard. It's two kilopascals, which is very low. And you can see four year olds can do it up to eight year olds can do it. And we've shown that device works. People with lung disease, we use our technology and another disease for hypertension, your lungs. And those patients have compromised lungs and interstitial lung disease and they use our same technology, same active ingredient outside of the insulin. I mean, you have to be an active ingredient. Yeah. And so you know, we know that it doesn't take a lot of inhalation effort to get the right dose into the body. Right.

Scott Benner 32:07
So your inhaler has a patent on it, and you use it with other medications as well. Yes. So

Michael Castagna 32:13
we have a patent on FTTP. We are putting on the halo rear panel manufacturing process to all this

Scott Benner 32:20
is all patented, covered. Are you going to get hit with the the orange book problem that are no,

Michael Castagna 32:26
we're protecting these in the 2030s. So I feel pretty good about the next decade, I would say it would cost somebody about $500 million to duplicate our plan. And it'll probably take them seven years and a couple 100 employees to figure it out. Yeah,

Scott Benner 32:40
maybe not worth their while. Yeah,

Michael Castagna 32:43
it'd be very hard. I won't say impossible, because I think engineering can always figure things out. But it'd be very expensive. And I think with the cost of making the product and marketing and probably everything in cost. It's a very tough business. We lost money for 33 years in those past

Scott Benner 32:58
year. And I was talking specifically about just recently, the FTC told some of those GLP manufacturers, you can't patent the injector and to buy an extra, what is it 30 months on your patent? And that whole thing is playing out right now. But I was but you're but it sounds like your inhaler is specifically designed so that it takes a very low amount of effort to draw in is that the idea?

Michael Castagna 33:25
Yeah, and the inhaler is our platform, it's not an off the shelf platform. And people asked me, I said, look, the inhaler, our powers go together, meaning if I took someone else's powder and put it my inhaler may not fly this time, it may not work is good. And if I took another inhaler and put our powder in it, the same thing would happen. It may not work the same menu different dose. So it's not an easy modification, meaning you know, you'd have to learn how to use FTK P and you have to learn how to manufacture at scale.

Scott Benner 33:50
And my question doesn't fit here, then it sounds like your device is very specific for a reason. I think some of those other companies were just like, hey, say the injectors different. So we can hold on to our patent longer. I

Michael Castagna 34:00
haven't worked on biologics, we'd often change buttons, colors, volumes, all kinds of stuff to kind of just, you know, make the patient's body a little bit easier or a little bit clearer. But yeah, you know, the drug is the drug at the end of the day inside the injector.

Scott Benner 34:11
It's fascinating how you don't think about these little things like this is apropos of nothing but I know there was one company that they had an injector but when it was all the way drawn out to give yourself a big injection people's thumbs couldn't reach the plunger. And they didn't realize that till they gave them out to people. And then they were like, Oh my God, and then they had to go back and change. It's just it's so crazy. Some of the stuff that has to happen. The answer here is if you try a Frezza it's going to be a little bit of a science experiment for the first week while you figure it out. And but you're going to but it's interesting because when you're like if it says six the eight cartridges is good, I'm not gonna get low then it's just why

Michael Castagna 34:47
well think about your changing the route of administration. So it's something called the bioavailability of the product and what you really want is to get anytime I go from an injection to a patch or an oral pills to a to an injection, those those has always changed because the body breaks down drugs in different ways. And so when you think about a president, we don't have this first pass metabolism that goes through the liver, we get it in the body, and it's active permanent livers. So that, but you lose some of the product in the in the device, you lose some of the product that you know, through your back of your throat. And so we calculate all that in there. So as long as you're inhaling pretty consistently for yourself, you're gonna find that those the doses are pretty much the same, meaning how you inhale every single day, some people will heal very quickly, some people have long, slow, but that those, your body's gonna figure out the right that this is, this is what works for you. And you're gonna say, Okay, it's typically take this much down or 12. And so the inhalation variability, we actually have a Blue Hill device that's called Blue Hill, and it goes on the back of the inhale, and we show you how to properly inhale in the office. And so that's something we can show technique. If you're struggling a little bit, you think you're not doing it, right. Even our best employees who use the product for five years, we show we take into our lab, and we show them how, like, Oh, I've been inhaling wrong, or I've been healing for too long. And it doesn't really matter to you for too long, it's not going to change the kinetics. But it's really if you go too short, that's why I tell people just two seconds, like as long as you because I've seen that, that's not going to be the right the right way. And then

Scott Benner 36:13
you're getting some of it, not all of it right and up in your mouth and then just gone. It's

Michael Castagna 36:17
gone. It's because insulin doesn't work in the gut, right? So the gut deteriorates. That's why we have another drug that we're doing that if you inhale it, you swallow it, it's gonna have some activity from the part that you swallow, it will have some activity that goes directly into the lung, and of blood. And so that's, that's more complicated drug development than insulin, which generally comes in there.

Scott Benner 36:34
So you said the the inhale, one study is almost finished, or is that your your right to present data,

Michael Castagna 36:40
we have two trials coming out, we started inhale one a couple of years ago, that's in kids. That's why it was one. And then the inhale, three study is an adult. And the reason we did three was its receiver of present and Dexcom. So we're trying to say, hey, here's a free tools you need in health rate. And in that study, we wanted to show that you could safely switch off an ad system or a regular pump, or multiple daily injections. And maintain control was the primary goal to study. And so it wasn't to show that it was better It wasn't to to show a better time and range. The main thing is everyone believes, right that AI D is the best system out there for you as a human being, or your child. And we want to show that you could safely choose an alternative and that doctors should be providing more choice to patients. So we've gone head to head against multiple daily injections in our trials, that's really shown behind what people perceive pumps to be a little bit better. And so that's what we wanted to be able to show that were as good as the standard of care that's out there. Kind of how you define it, you may define as multiple injections, you may define it as an ad system. And so we wanted to show you how you could convert from either process to maintain control and hopefully so

Scott Benner 37:50
what is control mean, what what do you mean, if I asked you what a one C and what variability could I maintain with with the Frezza? Do you have like an answer for that.

Michael Castagna 38:01
So our goal was to maintain a onesie. And we also looked at timing ranges, secondary analysis, so you can see, you know, whether you want it whether your goal is below seven 7.4, I think that's something we do in societies, we say, Oh, you need to be below seven. Well, the reality is 75% of people on insulin are not below seven. They may be personally okay with a 7.5, they may be fine with an 8.5. I've interviewed patients who say, Hey, I like my Starbucks every day. I like my food, and that's my life. And that's my choice. And I have to respect that. Right. And I think that's somewhat challenging from a clinical perspective, when else decide because you gotta get the goal. And you're, and you're failing, if you're not, and I think we don't we don't we got to accept people's choices. And so in this trial, can

Scott Benner 38:41
you give me a second, do you think a person who would categorize themselves like that as, hey, I have an eight, five, but I eat the way I eat? Would they do better with a Frezza?

Michael Castagna 38:49
I think if you dose your insulin properly, you can always do better. And I would say that with injectable insulin or inhaled insulin, right? It's about getting your Basal ratio, right. It's about getting your mealtime coverage, right. And, you know, remember, all you have is a deficiency of insulin, a normal healthy person, right, can eat whatever they want, and their body corrects it. So I just believe you got to just give the right insulin dose and it's harder with injectable insulin because it's less predictable, the further you go out. And that's what makes it harder with a president you just get that little bit more near term predictable. Maybe gotta give a second dose of a big meal two or three hours later, because you see your sugars are still 261 to bring them down to 150. So it just gives you a different tool to rethink about how you define control or how you want to be in control.

Scott Benner 39:33
So would it be fair to say that injectable or insulin through a pump is a game you're playing in like this four to six hour window, but with a Frezza. The window is more like 45 minutes to two hours, two hours. And so if I shorten the window, then I can decide if I need more insulin faster and not be worried about like a late and low later. So it's not necessarily that with a Frezza, I'm gonna see fewer spikes or even less spikes if I'm or less aggressive excursions, if I'm using it incorrectly, it's more about how I can come back at it again and again and again, and the profile short and it comes out of my body quickly.

Michael Castagna 40:18
So we would say our data would show you, if you were to use it at the right dose right up front, you would have lower peaks, your glucose excursions might be 40 to 60, instead of 90 to 100. So we would lower the excursion a lot. And we think those peaks have caused a lot of damage. Right. And so we do think reducing those peaks over time. As you know, we haven't been able to show that in clinical trials, nor have we tried in fairness, but but there's data out there talking about that, right. And so we do know, we work roughly 3040 minutes faster, and you can lower your peaks by 3040 20 points.

Scott Benner 40:51
So I still can Pre-Bolus with the President. I should retiming.

Michael Castagna 40:55
Yeah, I mean, why would you just take when your food comes, because what you're trying to do is suppress your endogenous glucose production. And the faster you can do that, and it doesn't really start to until you start smelling the food and everything right, then it starts producing pickoff.

Scott Benner 41:07
Oh, I see. So putting it in 15 minutes early wouldn't help me. No, you shouldn't do that. No, okay. Because

Michael Castagna 41:13
it works fast, right? So if you don't, then God forbid, you don't need for 15 more minutes, then you're gonna go home, be upset and be really soon as your food shows up. That's the most important part. You don't have to worry about guests hurry. You know, people say, Oh, I missed my, I forgot my insulin in my car or something. You know, as soon as you get back to your car, you get your insulin, you can take it no, it's going to kick in an hour. That's important.

Scott Benner 41:33
I feel like I cut you off earlier. I'm sorry. Like, so what's the what's in a one seat goal? Like in your label? What what do you expect that I

Michael Castagna 41:41
was gonna say is in this trial in particular, and then he'll three we lead 25% of the people in the trial, who had less than a seven a one C, which we've never really studied? The people doing the best, right? And could they maintain that control? versus those that aren't doing well? And can you maintain or improve their control? And so you know, that's this is the first time in one of our trials where we took people that were doing fairly pretty well. And the question was, would they stay there? Would they get worse when they get better? That have results aren't out yet. So I can't say too much. But just know when when people do see the results, we went down as low as 6.5 and 6.0. A once these always high as nine and 10. When I think about those people, the people that probably are nine and 10 aren't taking their insulin. And whether they take inhaled insulin ready to take your pump or they take them. Yeah, they're just not complying in many cases. Right. And when some people just don't have the right dosing, right Basal ratio? Yeah, I think that's another thing to pay attention to is, you know, traditionally, in type one, you're told that the percent your insulin units a day should come from basil and roughly 50% should come from bolusing. I think as we get to a Frezza, because of this higher dose conversion, roughly 70% of your Bolus units are going to come from your, your inhaled insulin 30% company or Basal when you get to your titrate try to get those. So I think that's what we're trying to get give you as goalposts, like, Hey, I was talking to a priest once about us, put on a friend and he was struggling. And I think as basil was, like 10%. And I said, I said, I can't tell you what to do. But I can tell you, your ratio is way off, you should go back and talk to your doctor. Right. And and I think that's, that's important. Well,

Scott Benner 43:12
I make a living telling people that it's timing and amount, this podcast is incredibly popular, because all I say about insulin is that if you use the right amount at the right time, and balance it against the impact of your foods, there's actually almost no reason to see an excursion whatsoever, but it's just a difficult thing to do over and over and over again, it takes a lot of effort. Let me ask you this. And I know it's not a label thing or something that companies but do you know anybody personally using a friend who has anyone seen the fives? Oh, yeah, yeah. Oh, you Okay, all right.

Michael Castagna 43:43
No, but I know that many of our best patients right are 545758 they compete. I always tell people look, the data out there less than seven is, you know, whether you're 6.5 5.5 Don't, don't stress yourself out trying to get the lowest a one C. But but stress yourself out trying to get below seven if you can, because that's where the damage is really occurring.

Scott Benner 44:03
Are there other things you're accomplishing that with you personally? Like? Are you on a low carb diet or something like that? No, no,

Michael Castagna 44:09
I mean, if you saw my lifestyle, right, I eat out a lot for work. I travel I have a Starbucks every morning. And so, you know, when I try to express to people, you know, I have my sugars were way out of control, right? I'm sure I eat a lot differently. But I feel like I have tools in my bag that helped me maintain good control. And so I do not stress over what I eat as much. And so that's that's something that I think a lot of people do stress over what they try and maintain low carb diets. So to say all I can't take that too high of a dose. I've seen our data, I mean, people are coming in to whether it's our arm or the control arm, they're coming into these trials 170 Premium 180 pre meal, you're so far from going low, that you have a long ways to go. So I tell people, right and these are patients come in our trials are out of control. And so I think about that, you know, what are you doing to get your Basal dose right, what are you doing to Get your mealtime dose, right? Because you should be coming into meal at 120 100. And whatever you can think about your postprandial spike, let's say you only go 40 points, you're at 110. Well, you're gonna be time and range all day long, right. And instead what happens is people are 170, they're afraid to go low, and to go on to 290. And two hours later before the insulin kicks in, then a good man to take another call center go on the 60. And then they eat a bunch and they go back up to 190 200. And so you're just this Yo yo, all day long. And it's very frustrating when it's out of whack.

Scott Benner 45:28
I'll never forget the first time somebody came to me and said, Look, you know, my blood sugar's 180? Should I still Pre-Bolus? I said, it's not a Pre-Bolus that one ad, it's a correction. And then you have this conversation, right? And this is how I tell people, I'm like, Look, you know, a person over here without diabetes, they're standing here before lunch, their blood sugar is probably 85, it's probably 90, you're 90 points higher to them asking me Do you think I'll go low? If i Pre-Bolus, 10 minutes before I eat up? Like, you should correct the 180 You should Pre-Bolus your food. And you know, like that you're correcting right now and eating at the same time. It's, it's, I mean, I tell people all the time, like if you if you said to me, You have one minute, you're about to leave the planet, what are you going to tell people with type one diabetes, I'd say it's timing and amount, just use the right amounts on the right time. That's it.

Michael Castagna 46:18
And if you look at a president's profile to a natural human insulin profile, we're the closest insulin out there to what your body naturally done. Right? Now, right, it peaks in 30 to 60 minutes, right, and it's out of your body in two hours. And people don't realize that, you know, most meals are cleared within two hours. And so they think, oh, dinner, lunch breakfast, I just looked at all our data, the doses don't actually change too much by breakfast, lunch, and dinner. In fact, what I always tell our patients is the make sure you get your dose right before you go to bed. Meaning if you have a big dinner and you don't take enough, then you're going to bed at 190 200. Now figure out if you can take a foreign aid, whatever is gonna bring you down closer to 100 while you're sleeping, because within your ticket, those are the 30 before you go to bed an hour later, check it to see where you are. Because if you go to bed normal, you wake up normal, you go to bed, how you're waking up, hi, yeah,

Scott Benner 47:08
especially with yours, because once I go to sleep, it's not like I'm gonna go into hell more. Whereas like my daughter, she's an Iaps. Right? Now she goes to bed high, it's gonna keep working her down overnight, what do I do in a high fat meal situation, do I have to a Frezza, wait two hours and then see that next rise from the fat and hit it again,

Michael Castagna 47:28
I said scientifically, we should do is take whatever dose you thought would cover that, that meal you're taking, and, you know, multiply by two and run now, which is what we're doing our trials. And that should cover the whole meal.

Scott Benner 47:40
So I can put in enough for the carbs and the fat rise in one shot, you could

Michael Castagna 47:46
take it right up front, okay, and you know, make it up. Because normally your body would just release more insulin on that on that bigger meal, right? Sure. And so you would take more insulin up front. And then when you do that, if present has a longer curve, right, the more you take, the higher goes the longer it list. And so you know, for I'll make it up as they all work about the same speed, they come out of your body at different times, right. So for you, it'll be done in about 35 minutes at 12pm Peak effect in 45 minutes, that's out of your body within 180. So if you're going to have this big meal, you're going to be 16 to 20 units a meal. And that's just going to cover you for the full 234 hours. Now I'll say that's the science, the reality as a human is, I'm going to worry the whole time and I'm probably going to underdose. And therefore I just say see, we're sugars aren't one hour, and those again, if you need to, or two hours, okay? And but the bigger dose you give up front, the better, you're going to shut down that endogenous glucose production. And that's what people don't quite understand. Because injected ones that just doesn't do that that fast. But if you can shut down that liver, you're shutting down the signaling pathway that's causing this huge rise, I say and the faster you do that, the better control you have. Because

Scott Benner 48:49
you're working with type twos. Will Will there be us that I'm spending your money over here? But Will there be a study with people using GRPs? I

Michael Castagna 48:57
don't know. I mean, we redirected our focus to type one diabetes. That's why you've seen us in kids with adults, pumps, you know, this is what we're focused on going forward, we are looking to bring your presence to the rest of the population around the world. So we will hopefully be in India by next year, Brazil, and us that's about a third of the world's diabetes population. And then we're gonna be going to Europe, China, and Asia and Australia. So we think that over time, you're gonna see it now be global, which is great for society, the GLP has worked pretty well. And so that doesn't mean that they're not delaying the use of insulin or you still need insulin I do think we're going to see in the long run, but everyone can tolerate GLP or eventually they were and you were talking about long term safety earlier about these things. It's funny because I I I tried to Olympic at one point and I just did not feel well. I started wondering like, Okay, what's the date on these things long term? So I called one of the manufacturers I won't say who? And they said oh, we haven't studied to be on two years. What do you mean you want me to take this for the rest of my life? So what will happen when a person stopped taking and what did they wants to do with their waking go back? We don't have any that they don't people discontinue we only people do. After the trial and followed up, so there is no when we asked me what inhaled insulin I can tell you, we studied it for two years non stop, we looked at I think they only have one year data on this one drug. And I'm like, and so now it's been in the market 10 years. So we feel pretty good about our profile. We're GLP is are still, you know, they've been around 20 years in fairness. Yeah. But using them for long term weight loss. And these other things. I think once

Scott Benner 50:22
they're really popular right now, we're thinking about like, the Stata. Right, right. Exactly the stuff that the you're shooting every day at one point right now it's all a crapshoot, I, I've lost 47 pounds on a GLP in the last 14 months. And thank you fundamentally changed my life. That's fantastic. My daughter's using it, it decreased her. I, my math tells me that my daughter will use 16,000 fewer units of insulin over the next year, because of a small dose of a GLP. Like, that's crazy, right? But I'm just I'm wondering about that. Because as you're talking, I'm thinking, there's obviously is obviously a population for inhaled insulin, like, obviously, and so you're gonna make it available for children. At some point, FDA is gonna say yes, it sounds like and then that's going to be another group of people who can try it. Now we're looking at people who might inject basil, do the inhaled, etc. so on then, but then people are going to hack it along the way. There's already people micro dosing GLP is, and like, so like, you're gonna I just was wondering, like, what happens once you really lower my insulin need, with a GLP, I have Basal insulin running in the background, and then I hit a meal with this, like, it's just, it's gonna be interesting to see what people do with it, and what doctors prescribe it. To

Michael Castagna 51:45
your point, you know, the kids, they don't will, this trial is fully enrolled. So the pace less patient will pull here in September, October timeframe will crunch the data in the fall. So we'll know on pediatrics very shortly. And hopefully, it looks good. And we'll file that with FDA next year, the inhale three results will we'll try to get will debate whether it goes up to now or later to try to change some things in the label around the conversion chart. But otherwise, to your point, you know, our job is to make people aware of the science, the safety and efficacy of the product. And we didn't have much money in the last seven years to fund a lot of that stuff. Now we have, okay, and so that's what I think you'll start to see nothing but new data. Now we got 30, we trial 17 weeks, primary endpoint 30 weeks of follow up coming out next year, you're gonna have keys, which will be a 52 week study and 26 weeks as a primary endpoint. And then we're just approving a gestational study that we'll look at friends use and gestational diabetes, and PK PD and make sure women can inhale properly, their diaphragm and all that you're seeing us invest more as we go forward. And we're not backing down from where we've been. I think this is a useful tool. And to your point. GLP has definitely reduced the need for insulin. But I can tell you looking at the National insulin statistics, the market stopped growing, but it's not shrinking. You know, more people have diabetes in the future, more people need insulin, you always know there's a seven to 10 year delay in type two now, maybe 11, or 12. Who knows? Eventually, we're gonna need insulin for patients. And honestly, if we can lose weight and use less insulin in society better off health wise, we're all federal, right? Yeah.

Scott Benner 53:16
So that's faster. It's fantastic. I appreciate you coming on doing this with me. I really do. I have to jump off. I apologize. I'm short on time, which is not usually what happens because I make a podcast that usually just I'm like I can keep talking. Maybe we can get back together and and learn some more again, I actually have some of your users like lined up this year to be guests. People are very excited to talk about it. So there'll be some of that there. But I really do appreciate you taking the time. Real quickly am I going to see problems getting it covered by my insurance? If I have type one, just

Michael Castagna 53:49
about say a scar? Don't let me leave it I'll talk about access. So generally, if you're type one, you're in a better position, then type two is because the insurance company wants to know you tried and failed their preferred agent. And failed means you could have hypo means you could anyone see could be 7.2. Right? So the failure definition is quite broad. And we've created a program that as long as you go through our pharmacy and reimbursement support, if it's not approved, for whatever reason we charge $99 a month, or $3 a day. So I've tried to take the excess burden off of society and say, people should have access to insulin. We think $3 A day less than a Starbucks these days with inflation is a fair price. Or it can I guess most states, and so that's where we are as a company. That's our position our policy and if anyone has any problems, they can feel free to reach out to me and I'll make sure we take care of them. But we want as many people have access to the product. We will work with insurance companies to make this happen.

Scott Benner 54:40
And it's fantastic. Thank you very much. Thank you

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