From Basement Lab to NASDAQ | Lew Bender, M. Chem. Eng, MBA Intensity Therapeutics, Founder & CEO

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Mike: Lew, introduce yourself to our listeners. Of

Lew : I did my graduate and undergraduate at MIT and I went and lived in Switzerland for a number of years and developed some very interesting biomedical products, came back, went and [00:02:00] got a master's of business at Wharton School at Pennsylvania.

And because tuition was so inexpensive there at the time, I decided to go for a master's in international studies at the same time. Why not? 

Mike: Course.

Lew : And so then I worked in the drug delivery business, not driving the trucks, but developing the technology to create the way molecules can move through the body. And, then I had this idea, about 12, over 13 years ago, almost, of a new way to treat cancer. And I decided to, Start a business, develop a new drug approach. And, here we are 12

Mike: Very much.

Lew : three products. 

Mike: Lou, one of my sons is studying chemical engineering and I've talked on the show before about this, but like a pharmacist, I don't know a damn thing about chemistry. I'm not sure how much he's going to know either. His is a lot of flow rates, dials and all this kind of stuff. [00:03:00] If you had to end up where you were, or if you wanted to end up where you were now and wanted to get the best degree to get you there, would it have been chemical engineering or would you have taken a different course of studies too?

I'm not trying to rewrite history. I know we can say, we are where we are and I'm thankful for my path. But would you have taken something different to prepare you more for what you're doing now?

Lew : This is a very complex question, even though it sounds very simple. I don't think I could have done what I do, or did what I did, without chemical engineering as my major. See chemical engineering is not just dials and flow meters and flow rates.

That's sort of like the mechanics of what ultimately you build. But chemical engineering is the physics of chemistry.

Mike: yes. 

Lew : Okay, and the math behind it, so, for example, while a chemist may come up with a new way to make a molecule with these complicated reactions, [00:04:00] engineer makes it practical.

We study things like how diffusion happens, and why it happens, and how, the thermodynamics of things, , where is it going energetically, where is it going physically. Biologists study pathways and they don't really pay attention to the practicality of how you get a drug to some part of the body. effectively. That's what an engineer does. It's what a physicist will do. So chemical engineering gave me a perspective on drug development and on drug discovery that a biologist or just an MD, because remember, you can go to medical school. You don't have to be studying the sciences. One of my good friends is a great nephrologist, who obviously helps a lot of people with kidney disease, but he was an English major as an undergraduate.

Mike: Hm.

Lew : the biology and everything to get into med school, but it's the, it's the chemical engineering, [00:05:00] the physics of how things work chemically. Why does this molecule react with this molecule like that? The physics, the math behind the kinetics of how they react and how long it takes. That's the discipline that I liked. First of all, I loved it. It's math and chemistry without having to do either of them. You can apply, it's applied mathematics and applied physics in a chemistry setting, which I really liked. So I would have absolutely studied that again because it's helped me and understand everything about the way the world works. the physics of biology or the physics of chemistry. That's the understanding you get with a chemical engineering degree.

Mike: If you told somebody that water was H2O, they might get that, but that really has nothing to say as far as I know, it doesn't really have anything to say about the properties of water, like how it's moving and then it feels [00:06:00] wet.

And then it looks like a liquid and all that kind of stuff. It kind of got me thinking about that. Like the chemical equations here, but what that does is sometimes like a whole different story, it seems.

Lew : Let's talk about water a little bit, so, water. Let's take a bowl of water. What's happening at the interface of the air and the water, the liquid water. What's happening there? Well, there are molecules going up and there's molecules coming down. if it's hot, there's more molecules going up. And if it's cold, there's less molecules going up. it freezes and there's no molecules going up. That's the physics of the water that we learn. Why does water spread, , on, metal or wood?

Differently when it spreads on Teflon? Well, it's a

That's the physics of the surface, tension between the water and why it's a [00:07:00] sphere. Why is it a sphere? Because, the ratio of surface area, to volume is, minimized a, in a, in a droplet, 

You have the physics of just looking at water in a glass. It explains everything. You can understand vapor pressure. You can understand boiling rates. Boiling some water at the top of Mount Everest is going to be different in terms of what the energy needs are. And if you're boiling it in Death Valley, the understanding of just boiling water, where it is and what it is and what the pressure and what's going on at the vapor pressure, that's what we study in chemical engineering. Now you think about all the compounds in the world and all the things that are happening. You're studying the physics of what's happening with these molecules that are , in our daily lives, the particles we breathe, viral particles. These are fundamental physics of what's happening and how we get infected with disease. , when COVID hits , you understand why they want to wear a mask. What are masks doing? What are they not doing? What can they do? I'm not going to comment on what's right or wrong here, [00:08:00] but ultimately, 

chemicals.

is what chemical engineering is doing, that's giving me, gives you a perspective. Everything I do, everything I look at, I see through the perspective of the math and the physics of the chemicals that are around, around us on a constant basis. and that's very, very helpful to understanding and sorting out.

If you learn it really well, if you really understand the complex interactions that are occurring, you see the world, Sort of like in the Matrix, where all of a sudden , he saw the green numbers.

Everywhere I look, I see the green numbers of where the molecules are going.

It's kind of a discipline that I feel has helped me to become, , the red pill or the green pill, the red pill or the blue pill. I feel that I can see the world through the eyes of the physics and nature of chemistry. So I see nature through that mathematical, physical nature.

 To go back to your question. see [00:09:00] cancer in a way that's different from a biologist or a medical doctor. They see the symptoms, they see this, they see that, but I saw it. for what it is decided to do something about it from my perspective, which was to understand how drug delivery can make, potentially a better product to help people with cancer.

Mike: So Lou, in my case, being the business of pharmacy podcast, I'm not allowed to talk about medicine because I would botch it. I'm probably the only pharmacist that goes out to my little old lady customers and has them explain something to me. So the actual molecule.

That's something that you didn't touch a whole lot, but you're touching more of the delivery of it to the body. Is that close?

Lew : Yeah, I mean, really, whenever you talk about any medicine, the medicine has to get to where it needs to be in the body at the right amount, the right time and the right dose. And, that's all kind of a physical thing, 

Then, , what you're really trying to do is you're trying to [00:10:00] find a better treatment for the disease by delivering the best molecules possible to the right place at the right time in the right way.

You want to minimize side effects. You want to maximize the effect. And that's all physics and natural physics of the chemistry of the medicines that we're trying to create. It's very important if you're going to give something by mouth, or if you're going to give something intravenously, or if you're going to give something intramuscularly.

All those drugs, the same molecule will behave, and so you have a lot of different things. It's not just the medicine, the molecule, it's the way we deliver it. That's important. I mean, a pill, IV, intramuscular, intratumoral, which is what we do. These are all additive properties of how your treatment goes. and, that's what we're trying to do is to try to minimize, keep the drugs in the tumor. I don't want to get into the medicine of it, but

What you study at chemical engineering is a [00:11:00] new perspective on how to create a better pharmaceutical product in any sense.

Mike: Again, without getting into too much detail, Your drug that you're working with. Is that like a patent from another company? And then you've taken that with all the stuff we're talking about. Is that fair,

Lew : So, I'm your classic entrepreneur, I started doing chemistry in my basement and I'm the inventor of our way of delivering the drug into the tumors.

Mike: But you're not the inventor of the compound, did you get that from another company? Would you say,

Lew : So there's three components in our drug. All three of them are old generic off patent combinations. In this liquid formulation that I created, all cancer drugs are given one of three different ways: an injection into the muscles, an injection into the vein, or a pill in the mouth. [00:12:00] And we're creating a new way with this new concoction that I created by injecting it right into the tumors wherever they happen to be. You don't have to hit every one of them, just hit enough to kill the cancer and stimulate from your own tumors your own personal anti-cancer vaccine. We are killing the tumor. We are converting it into something that as it dies can be recognized by the immune system. And this is all physics and all the way we do it. and it is now something that the immune system can hone in on like, bees to honey,

Lew : they hone in, and they now can, adapt and recognize the cancer as not something that should be in the body as we kill it, and they go off and they hunt down the cancer we don't inject.again, this is all, a physical process of Directly injecting into the tumor with this delivery technology of three molecules that are very well known and very [00:13:00] well established, obviously nobody that ever put these together and I had to understand what the magic molecule that we created.

the other two drugs. Ultimately, this is something that's never been done, and I looked at the problem of cancer from the point of view of a chemical engineer. you have cancer, have tumors you can see, and tumors you can't see. Little pockets of cancer cells that you don't even know you have. And to make somebody live longer and feel good, how do you destroy the tumors that are visible, and how do you get to the tumors you can't inject or you can't even see? That was the problem I thought I had to solve. The way to do that is to kill the bulky tumors as much as you can. This new drug gets the tumor to die in a way that allows for the immune cells to come in and recognize that cancer, and then go out and hunt down the cancer we don't inject. so people

don't have these off target [00:14:00] toxicities.

in the tumor and it doesn't go all over the body. And then it sends out. signals, antigens, chemicals that can be recognized by certain types of immune cells to go down and train other immune cells to hunt down the cancer.

Mike: Now Lou, with your, uh, and things like that, are you as passionate about this? I know you're passionate about your business. Are you as passionate about business in general? Like, if this was done before somebody, maybe didn't do it right, we're going to get FDA clearance and then we're going to do this in a different way.

Do you have that kind of passion for the business part of it? Or is that kind of the boring part?

Lew : Science is easy. The business is really hard

so financing is really hard. making investors understand how, how what we have in a new way and getting them over the hump is really hard. [00:15:00] Business is the hard part. Okay.

The idea looks like I've helped, I help a lot of people so far. We understand the drug now we're going in, we're in phase three. We're in phase two drugs going. It's the business that's, that's really hard. lemme tell you, when I started this, I had this idea. So I go to my wife and say, I have an idea for the treatment of cancer and I would like to quit my job.

I was the CEO of a company and I wanted to, I wanted to, leave. 

It was a genetics testing business, genetic testing company. and boy, you want to know real hard? The business of diagnostics is even harder than the business of drug development and making money in drugs. That's another podcast, and we could go on for another 90 minutes just

how difficult the diagnostic business is for

and the value they create and all this other stuff. very convoluted. So I had to get out. It was too hard. The business was too hard. Finding a business for cancer is much easier than the business of [00:16:00] diagnostics in my mind. at least it was for me. So look, the story was, I went to my wife, I said, , I'd like to, I have this idea for cancer, , and she says, well, you don't, you've never worked in cancer. I said, I know I have my perspective of chemical engineering. And I said, and she says, well, have you ever done research? Well, no, I'm an engineer. I don't do the basic research. and, , she said, but they're spending tens of billions of dollars a year on trying to find better treatments for cancer. Think they're doing it wrong? I said, they're not doing it wrong, but they're doing it in a way that's not what I think should be done.

I think I have a better method. I think I have a new way to do it. She said, but you've never done research and don't know anything about cancer, but you think you, the genius, have a greater idea. You just, , you have an MBA. Oh yeah, big guy, MBA.

know anything about cancer? Have you done anything with cancer?

Can you really say what that is? You need to help people with cancer. So she kind of says, I said, all right, what? Maybe I'll go and I'll go talk to my [00:17:00] board and see what they say. They basically said, well, if you have an idea for a business and tell them exactly what it was, if you have an idea for a business, then go do it.

In fact , we want you to do it. In fact, we'll give you your buyout and you go do it. I said, well, guess what, honey? they agree. I should do it. But I think I have to leave in order to do it. So I said, I still think I have an idea and this is what we're going to do. And by the way, we're going to put our kids' college money into it.

Cause I'm not going to ask anybody for money before I have some data to show that. This works. I took some of my kids' money. I left my job. I got my contract bought out and I never looked back. 

Mike: Well, Lou, the question if you didn't look back, did your wife ever look back?

Lew : I think she's okay with it now that we went, took it public, , it must've been some worry. I was at a cocktail party. I had just generated my first set of data. It was very promising. And one of my friends comes up to me and he says, what are you doing now? [00:18:00] You're still going up to the company in Boston.

I said, no, I'm, I'm, I'm at home now. I, I, I am now trying to do this new, new, new idea I had. And I explained to him what it was. He said, yeah. I'll give you a hundred thousand. So I said, really? He said, yeah, another guy comes over and he gives me another good amount of money and then it just grows.

And from friends and neighbors I raised 2 million, just like your classic guy out of the garage. But I was in my basement and I raised a couple of million dollars from friends and family. And , my wife was frantic. You can't take money from our friends and family.

they want to, they want to give me the money. They know that there's a big risk of it. Well, that it's not working, but , it's an idea. that I have to help people with cancer. And how could I not try

a good idea and I just stayed in a comfortable job, I was CEO, I was making good money. If I just wanted to stay in a,

job [00:19:00] running businesses that were interesting, but nonetheless, not my business could I come to the end of my life and say, I think I had a good idea for cancer and I never did anything about it? 

That would have been a regret and I always felt I could get a job. What would it have taken for you to feel bad about the investment that you're making? Friends and family made. And here's why I ask if it's like, you might say, well, maybe this wouldn't have worked out and they would have lost it. And I'd say, well, do you feel bad? I was like, no, we knew it might not work.

Mike: Is there any part of that where you would have felt bad for doing that? or everybody kind of just knew that, you're going to do your best and then they believed in you.

Lew : I would have felt terrible.

I would have felt terrible if I had the idea. I would have felt terrible. a lot of, a lot of weight on my shoulders to take people's money and then not work as hard as I could and not deliver something. It would not have been [00:20:00] good.

I'm not the type of person that just says, oh, La Di da, I took your money. I'm sorry, I lost it. No, no, no. I was worried. I mean, I did not want to take my friend's money. First of all, they had to be qualified investors.

 I had a guy that was, um. A blind and he made his money by working as a ms, a massage therapist for people would come

and he earned, , only with what he had from his hands. Right. And

, for a hundred dollars an hour and he wanted to put in a substantial amount of money. And it was like, he cannot lose this money. I cannot take money from that guy. First of

qualified to be an investor. one,

Well, what you do is you take money from angels. they have to be qualified investors. I mean, they have to have a certain income, a certain

and then

of this, you can't take money from just about just anybody.

First of all,

if you want to do it right from a quality investor point of view, they have to be a qualified investor, certain income, [00:21:00] certain salary, a certain number of assets in order to

the money on,

 They were all qualified investors and even though they were all , knowingly, giving me the money with the possibility that it would fail and that they would lose their money, it still may fail right now I've given them an out we've gone public, we've taken the company public, but, they haven't made a lot of money and, , but they're seeing results and we've had really good results on from patients that they've seen and we've treated 200 patients, but I would have felt Absolutely terrible.

If I'd have failed early and not had the chance to even get into people or to a clinic and you have to go through a massive amount of work to take a drug idea, make it, make it under good manufacturing processes, get it into people, show the safety. You have to start out with low doses and work your way up. I

It was a lot of work, and I knew what the workload was, and I knew what I had to do because I had so many years of experience developing [00:22:00] drugs and developing this delivery technology for an oral delivery. I mean, if the drug ribelsis, which is an oral form of the GLP 1 protein ozempic, helped to create that technology, 

so I knew the physiology, the pharmacology, the toxicology, the drug manufacturing, the patenting. I knew all of that business and technical aspects. I had done

so I had a wide breadth of not only technical, but business, finance, Patenting law, legal stuff that I had good experience with.

So I was going in with eyes wide [00:23:00] open. It wasn't like I had to learn a lot. I knew how to, I needed to apply it, had to learn all that stuff too and everything. Figured out my headsets tonight and got my camera to work after you

 So it's like I had the experience.

I just had to put it all together to try to really make this thing happen. But I would have felt terrible if I'd have failed early. I really 

would have. on my shoulders for the time I was doing this. I still do,

Mike: At some point, like you said, it goes public. And so they might not get a huge payoff, but at least at that point, they can say, I didn't lose and I'm, I'm either still in or not, but at least you're kind of back to even there. That's gotta make you feel good. Like you say,

Lew : It's very satisfying to take a company from an idea in your head to a public company on NASDAQ. But it's not enough because what I'm doing this for is the patients. 

Mike: Not good enough for you. But I mean, at least somebody who got in, got the seed money in and stuff, at least they [00:24:00] can bail and you're feeling okay that you didn't, lose that for them.

Lew : Yeah, look, certainly I'm glad of that, obviously, if we'd have lost, but I feel like I carry the weight of this new technology, this new, totally different approach to treating cancer that seems to be very, very effective and fair with a favorable safety. I still carry the burden of until I get that product to the marketplace, I don't consider all the success I've had over the 12 years to be sufficient to make me feel good. I will not feel good until the FDA says this product will help people with good safety.

Mike: With the FDA, do you have to press them? Are you on the phone? Like, come on guys, this and that. Or you send it and you just like hands off until they put their blessing on things.

Lew : First of all, let me tell you about the FDA. I have the utmost respect for the FDA. The FDA has a hard job. There's a lot of things that don't work and they're dangerous and they have to sort the good from the bad and there's not [00:25:00] that many really good. And they are science driven,

understanding. If you've got good science If you have something that looks safe based on the number of side effects and the toxicities as they define it. And I understand exactly what they look for. if you've got something that's going to keep people living longer and feeling good, they, they will, they will buy into it.

If you can show them 

And so that's how I am. I am data driven. I am. able to make sure that we are generating quality data safety and efficacy data presenting it in a way to show the FDA the data in its totality in a way that tells the right message about how [00:26:00] well or not this drug works. 

Mike: Is that pretty much hands off with them? Are you just dealing with Official documents and stuff? Or is it more like, Hey, is Charlie there? I need to talk to him about this or that. Do you get to know the people at the FDA or is it pretty much just forms and documents and that kind of stuff

Lew : I get to know the people, you're not friendly , I'm not going to take them over to my house, but you get to know them. I've met with the head of the division of oncology and in both the breast cancers and the sarcoma divisions,

are very interested in what we do. And rightly so , our manufacturing has to be as good as Merck's and Pfizer's. It has to be as you meet the GMP, a good manufacturing process quality qualities of, of, of any drug that has to be reproducible. And as you have to demonstrate reproducibility, you have to

ask for some sort of. Fast Track, which we've [00:27:00] applied for and we received, or Orphan Drug Status, which we applied for. You have to prove to them that you are meritorious of it based on the regulations. Read the regulations, you provide them the information they need, and they will give you what you deserve. the

I find them to be very straightforward.

Mike: How is the speed of the FDA in general? I'm not talking about your fast track, but is it kind of like, was expecting to hear from this, last week and now it's been four weeks and all they had to do is X, Y, Z. , or does it move along in your mind?

Lew : So the FDA has always met the timelines that they say they're going to meet, and you submit what's called an investigative new drug application. They have 30 days to review it. Okay. They do it. They do it in the time they say they are. The regulations are this, they do it. When we've submitted something, they have met our needs within the time frame.

I didn't get everything I wanted all the time, [00:28:00] but

time frame that they say, and , , you request a meeting, you're going to have 60 days for them to schedule the meeting. And it's done within 60 days. regulation, they follow it. They meet their timelines. Now they may say, , you might need to withdraw this.

You didn't prepare it right. They work with you to make sure that, , when you have the meeting, it'll be successful. So you may have to adjust and they give you coaching and they are, I'm telling you, they want new medicines as badly as patients, doctors, and pharmaceutical companies do. They do.

And if you've got something, they will work with you. And they do it under the timelines that they set as the regs. They are required by a certain amount of time,

regulations to meet your needs within a defined timeframe. And they do. And they do it.

well.

Mike: how about them versus who you had to deal with for your public offering? I don't know, the FTC or whatever. How do you compare the FDA heads to the [00:29:00] other heads you had to do on the business side of things?

Lew : Well, that's another story. Again, there's a lot more complexity to the SEC filing,

for an IPO this, in this world than the FDA straightforward, , you got your data, you give your data. This,

not patients in the case of the SEC, but for investors in the sake of SEC.

So they are demanding your financial statements. They want your auditors, they want it to be PCAOB, which is the quality that you have to have in order for them. There's rules. Now this is where my CFO and my accountants have to come in because I know enough accounting to be dangerous, and I know enough finance to be dangerous, but let me tell you something, that is hard. The hardest thing I ever took, the hardest class I ever took in my life was accounting in my, during my MBA. It was just, [00:30:00] did not make any sense to me. Sorry. It's made up of science. It's made up of math. They want to do it to

investors. I understand the need. Protect investors, and that's their goal is to protect investors.

The FDA to protect patients. The SEC is to protect investors. And rightly so, because there's a lot of things that are, , scammed. , frankly, there's a lot of fraud in the, in the

 like anything. They got regulations, they got standards. Would I change some of them? Could I do that? Probably, I'm not the accountant to say what should be changed and what's

rightly so. They're protecting investors. I buy

Mike: [00:31:00] yeah, Ok. Besides all the rules, once you did that, was there anything that you said would have been nice if I didn't have to do this part of it, or is it?

It feels fairly reasonable what put you through?

Lew : Yeah, look, again I didn't really understand that process as well as I understood pharmaceutical drug development. I came into, , this is, I'm a drug developer, and I

I have business acumen and everything else. I didn't have a lot of experience working with the SEC, even though I was part of a public company.

I was the CEO and I understand that,

 I knew all the financial reporting requirements and all

I was CEO of two public biotech companies before, but I had never taken a company through the IPO process. That was a learning experience for which I could write a book right now. If anybody knows, there's this form that you have to file called an S1. It's very, very complicated. It's got a lot of risk factors and everything. And when you're launching an IPO, you got to know all about, , all the risk factors, you got to [00:32:00] comment on COVID's impact on your study, on Russia's war with Ukraine, on your, you have to have like a list of a million things in this this very, very, it pulls together, I think our document was 540 pages that we ultimately needed with the, with all the attachments and all the contracts and everything that had to be disclosed, we pulled that together, and Again, once you're through the SEC process, you got to get investors. there has to be a market and the market isn't dependent on your company. It's dependent on what the market conditions are. And if investors are not investing, they're not investing. 

thing in the world and they're not there. And the key in that respect is to always be ready. If a window opens and there's a finance and there's financing possible, you have to be able to be prepared with your S 1 to jump through it. And so after, , we started in July of 21, we closed the IPO in June of 23. It took me two years, but [00:33:00] we 

what we had projected. And you got to make projections, what, how much money you could n't know a priority. And we raised 22. 5 million. had demand for a significantly greater amount, but I'll leave that on the table at the time because, , we had made a filing to say we would raise between this range and that's what we were stuck with.

So we raised Top of the range at the top of the pricing allowed by the SEC. We put in a good amount of money to allow the drug to keep going and then we were a public company. I've done that before. So I know what I was getting myself into, with being a public company CEO.

I didn't know how to go through the birthing process of becoming a public company. [00:34:00] And

I feel really. empathic for people who go through this process . It is like giving birth. It is, it is probably not as painful as what women go through when they give birth,

Mike: Oh, of course not. No, don't, don't go there, Lou.

Lew : I'm not going there, but 

I mean, I didn't sleep. I mean, it was really, really, really tough for months and months and months. I was running out of money and, and , it was just a very painful experience because of the market conditions, not necessarily because of the data or because the SEC, it was just the market conditions were bad.

Terrible. There

There was a war in Ukraine in 22. If you'll remember during the middle of our IPO, we'd had a price, the deal. And then there was a moratorium on IPOs because of manipulation by Chinese investors in the marketplace. And they put a pause on all of them. Didn't matter what your company was.

All IPO micro cap companies were stopped. I mean, it was just one uncontrollable factor after another that was happening at the time. But you persevere. Yeah. Persevere and you and we got it [00:35:00] done

Mike: What is the worst part of you that made this difficult? And if you said, if I was a little bit more like this, it would have been, maybe smoother, if anything.

Lew : Well, let's if I'd had a billion dollars It would have been a lot easier.

Mike: It's gotta be inside of your brain. 

Lew : It can't be

Mike: not inside your wallet, 

Lew : All right. Look, Again, could it be my parents be rich or something like

Mike: nothing to do with money. Are you impatient? Do you have anger problems? Are you too agreeable? Are you too disagreeable? What's inside of you that you say, if I was a little bit more like this, this could have been smoother, or are you perfect inside? Luke, get your wife on the line.

Get her in here.

Lew : Look, we don't have time for all my deficiencies to be described, which my wife and my kids and my sister can accurately do 

Mike: pick the biggest one.

Lew : But look, I'm [00:36:00] pathologically honest, which is a problem. I'm a little too blunt when it comes to

and I'm not really afraid of telling people what I really think.

and that's sometimes I could be more diplomatic and I'm learning

 It's not that I don't have patience. It's that. know, I really see the potential to help a lot of people for what we

 , it's not about what we have. It's about how people can make money.

, it's not, you know,, my stock going public was because they couldn't make money because we priced at five, we opened at five 95. We went to six 75, everybody who was in that IPO was selling and they made a lot of money.

I find that it's not so much about The technology of the drug as it is about what's going to happen and how you're going to make money. I find that's the real world. I get it, but I think we should be helping patients. And, and , I look at my data objectively and I say, well, we can make this better and we can do this, but it's still really good. And I see what gets [00:37:00] funded vis a vis what I have. And I see how much hundreds of millions of dollars are put into things that are Not likely going to work because they've already failed and they're not much different than what's already failed and why are they getting money and I'm not and I could be, , a little bit at, at convincing, trying to convince people of what we have with, more tendencies, which

don't have.

Mike: And as you say, you guys care about maybe the altruism of what you're going to do and all that. But once it hits the stock market, there might be some funds that maybe people have, but basically is it going to make them money or not?

Once it hits that level.

Lew : The reality of the world is Wall Street is about making money. Anything else doesn't matter. And, and I, and you have to accept that. I

that. What's frustrating is that I know I'm going to make the money if I had the money to push the phase threes [00:38:00] and the phase twos. And we're getting to the point where it's really hard to look at what we have with 200 patients and, , , if this does work, it's going to be worth a lot more than it currently is today. You just have to persevere and just understand what people want when they invest. They want honesty and they want to make money. Maybe not in that order. They want money and they, they want to make sure that

So I understand it and I just have to continue to work on the way I pitch to give people a sense of how this really is objectively without hype, without anything other than this is the data and hope that I can continue to get the capital that we need to continue to push forward.

Mike: How does Wall Street, how did they get their [00:39:00] information about guys? to decide to invest for that. I'm sure there's all kinds of investment guides and so on. And how often do those kinds of things happen? Tap you for information about how you're doing. I mean, weekly, do they see something or is it just at your yearly reports?

 How does the world decide at that point if they're going to invest more in intensity therapeutics or not? How often do they get those? Insights from wherever.

Lew : Well, look, whenever we have news, we put out a press release. We have a PR firm, an IR firm that helps promote it. gets covered in the, in the trades. We put out data at conferences. We put out our quarterly updates. We put out 8K filings. , we're competing.

We tweet out things. We use other social media and platforms. There's a website that we have. We write publications. [00:40:00] So you just keep going and you build credibility. We partnered with the National Cancer Institute for which we've published data. We partnered with big pharma companies. We partnered with government agencies in the U S and Switzerland. We had a CRADA from the National Cancer Institute, a collaborative research and development agreement that funded some of our research. , we have the FDA interactions, which when we get orphan drugs, or we get.

Fast track. We put out news on that. So, we continuously update, , as a public company, we have a quarterly 10 Q and annual 10 K has a lot of detail. I'm constantly talking to investors. I get my investor relations firm puts me in front of investors. 

We give them updates, constantly

promoting and, and talking about what we, what we have. And, , as I said, we got the IPO done and I think it's just that right now the markets are fairly Fairly unstable with, , the

happening and,

and , a new administration, some very good things that could be [00:41:00] coming out of that that'll help biotech and help business. So it's all a confluence of, of events in the world and in, in the markets and in the people. And , the bottom line is. When there's certainty, it's easier. When there's less certainty, it's harder to raise money. And there's a, we're in a transition period and it's always more uncertain times to, it's harder to do things like that. But , eventually times change and all of a sudden the markets open up again and, and things get really good. And, then if we're out there and people recognize what we have, and I've done my job of building a foundation of relationships with the investors and showing that we can execute, , they'll recognize what we've done.

And I mean, I've been around 13, almost 13 years and, and, , And if you continue to do that and do what you say you're going to do, then people, people respect that. And they look at it as what you've got to do.

Mike: So Lou I'm thinking of competition. And once you hit the stock market, [00:42:00] your competition is not really another cancer drug. It's really, does somebody want to invest in something else besides these beach balls or whatever? You're competing for the brain of somebody who thinks that.

You're going to make them more money than someone else, basically. Cause like we talked about, they don't care what you do.

Lew : You're absolutely right. Look, there's fads that go on in investment. I mean, right now you're in an AI fad, I mean,

ai in their name is, is, is raising a lot of money.

I remember 1999, it was the. com. ,

, red herrings, these, these business plans come through where the more they sold, the more they lost

But they could raise a hundred million dollars and they were doing that. So there, you're absolutely right. Mike, that the competition for investment dollars now is flowing to tech and AI in particular. The valuations of some of these things are just enormous. and , we're competing with that. And

and cancer in particular [00:43:00] is a challenging market time right now in terms of the progress that's being made. So you have that, you have that factor as well. And that's why I have to keep saying, look, here's why we're different. Here's what our data is. We're different. Hello. We're different. We've got data on this many people. We've shown this kind of survival. We've shown this kind of safety. It's very, very good vis a vis all the other drugs out there.

We're in the late stages of development. We're a couple of years away from having our potential data readouts. I just, you just gotta keep repeating, repeating where your progress is being made and what you're doing to compete with the things that capture a lot more news. AI is right. 

I remember where the internet was. com was it. And

in 2020, the COVID vaccines hit and biotech was there for a while there. And COVID vaccines and COVID treatments and all this stuff. So the market changes but if you keep persevering and you've [00:44:00] got something that really works, eventually people will find it. I just gotta keep going.

Mike: Lou, not from a medical perspective, but from a stock perspective, you said that Cancer medicine might not be, I don't know, real exciting right now or whatever. Those are putting words in your mouth, but what are investors seeing about the cancer market that may be, it's not as popular as, we'd like it, or it could be, what are investors seeing in general about the cancer market that maybe they don't like as much?

Lew : Well , I turned that around. I said, well, where's been the excitement in the last few years in cancer? Know, in the last couple of years, , you've seen some, some interesting things in, in some new technologies that are, , very early on. But some of the big immunotherapy products were not much better than the current immunotherapy products.

And there's patents coming off. , look, you do the same thing over and over again and expect [00:45:00] for a different result each

that well. Their antibody drug conjugates look very promising, but they're very challenging to make and their benefit is, , hard to, to, to achieve. You have to do large scale studies and for smaller companies, it's very, very challenging to do these kinds of things. So, there are jewels out there, but if people are looking in a different store and they're not buying Jewelry, let's say cancer is drugs and jewelry. They're buying the latest app or they're buying a new electric vehicle. Then they're not in your store.

You've got to attract them back to your store with something that's really glistening. That's what we have to do. got to get them

some glistening data. 

Mike: And I agree completely about AI, you get AI in your name. Have you seen [00:46:00] any drug companies or similar latch onto that AI, know, the pizzazz and you see something happening with them. And you're like, they're not doing anything. They just put that in their name and got more attention.

Do you see that happening in the drug market too?

Lew : I get 10 emails a day, that are pitching me some sort of AI service that's related to drug development, every

I mean, it's all over the place and you see deals where companies are signing up with AI companies all the time. I read three or four books on AI. I've, I've studied, I got to NVIDIA's website and I learned about their parallel processing chips. NVIDIA is the big AI chip maker. They got it. 3 trillion valuation. It all started in gaming, they had a parallel processing chip design. Everybody else wasn't doing that. They kind of captured the market because that's what's applicable for AI, chat [00:47:00] GPT, , open AI, all of these Grok, all of these , Copilot, all of these AI services that are coming out. I've, I've learned about them because I said, I need to understand what this is. Can it really help me or not? And so I've, , I've read extensively about it and I've talked to people who are chip designers and they explain things to me. So I kind of have a very good feel for it and what its limitations are and what the risks are and what it can and cannot do.

These language models that they create are very, very useful in a lot of applications. And I use AI. I use it when I write now. I'll use Grammarly, which I think because, , I'm an engineer, do I write well? I, , I can put a couple of sentences together,

can't write like Hemingway, 

 I use some of these AI tools to help communicate and it's been very helpful. I've been more effective when I've applied some of these

to, correcting and clarifying some of the messaging that I want to say. It's

that way. Will it help make drugs? Maybe. I don't know. They couldn't have done what I did [00:48:00] because I think H. I. is better than H. I. human intelligence

is still paramount in terms of creativity in my mind. Genitive A. I. is very good at giving you more ideas than maybe you would have thought at, but to, to really hone in on what's practical. an idea as opposed to just a generative AI idea is still going to require human thought and human consideration that's not capable of being done by the AI technologies that are out there. 

Mike: Lou, where is cancer down the road ?

Lew : Well , look I believe we are a local, locally delivered therapy. It's not systemic, but it treats systemic disease. The safety is very favorable compared to what we have. One of the things about cancer that people don't recognize is that people are afraid of the treatment as much as they are of the disease because it's so toxic ..

with, with what we have, you can inject the [00:49:00] tumors, the drug stays in the tumors, the tumors die, they convert into something that's recognized by the immune system. And I'm thinking, and I'm at Kitty Hawk right now. I believe that what we have is potentially, and not yet there, obviously we have to show it, but if we can show that a local therapy can treat metastatic disease with the kind of safety that we're showing, that the doctors and the people who will come after me and after this first product will just blow away the rest of what's going to happen in cancer. I believe we are on the cusp. If my technology can work by creating another Wright Brothers moment, but for cancer. Now that's a very bold statement. It's what I firmly believe. I've got to prove it. People will dismiss it. It's hype. It's everything that I say is not believable and they're absolutely right not to believe it until we do it. And hopefully we'll get the capital to do it. Where can cancer be? It's going to be a lot [00:50:00] different than it is today. I hope it's going to be safer, I think it's going to be a chronic disease where, okay, you get your cancer, you get it treated. It goes away.

You come back. Maybe you get another treatment in a different way. That's kind of what we do with targeted therapy. Now you keep mutating, but I hope someday that we will really extend, , since Nixon signed the 1973 war on cancer act, the average age of people. Getting cancer is 69. The average age of death is about three years.

It hasn't really moved. Every year there's about another five to ten thousand deaths in the United States from cancer. Six, over six hundred and twelve, six hundred and fifteen thousand people die every year. The same number has been around for a long time. It's just not changing in terms of the number of people and the percentages of people.

It's going down in terms of the percentage, but we're still losing way too many people. 1800 people a day died from cancer.

[00:51:00] heart disease is below some other death rates. We want cancer to be a chronic disease that maybe it'll kill you when you're 80 and not the average age of 70 or 72, whatever it is. That's where I think we can be, and we can make it.

take the fear out of it. We can take the fear out of the treatment. You don't need to be on it for the rest of your life. We can maybe get a treatment where the cancer gets killed, the immune system gets activated, you're off drugs after a year, and you're good for a long time. And then if something happens and it comes back, there's another product to come in and get rid of that. And you monitor it better. Monitoring is always critical. , we're getting [00:52:00] way better at monitoring more mammograms, more cancer identification technologies will come into play.

You get it early. You can, you can cure it, so that's what we need to do.

We need to focus on better treatments that are safer treatments better detecting, and I think that's where the industry is moving and I think, we're, we're going to be there.

Mike: Where do you want your company to go? Let's say that you get clearance on this or whatever that's called. And, and all of a sudden then , you're doing this. Would you like to be producing, thousands and thousands of, of drugs coming out of your building and putting them in the Brown boxes and putting shipping tape on them, or when that point comes, will you sell that and then be more of an inventor again?

Lew : number one thing when I started this company is, whenever I make a decision, it's what's in the best interest of patients. Okay? So, when people say, what's your business strategy? I say, what's your business strategy? My business strategy: if we have an effective drug, I want it in as many [00:53:00] countries and as many patients as possible around the world. So if somebody says, we're a big, big player in this and we'll help you then that's, that's great. You take it over. You, you. Commit to giving this drug to as many people as possible, then I'm all in. , you can buy me out, whatever is best

If there's nobody willing to do that, I will do the best I can to try to deliver these new products to as many people as I can with whatever resources I'm allowed to have. But Everything that I think of when I try to make a decision about what's, what should we do, whether it's to finance at a very unfriendly financing set of conditions. But if I need to, I do it because that's going to be in the best interest of patients. If we, if we don't stay in business, then that's not in the best interest of patients.

So whatever we

do to, to survive, to get the drug into patients and to be as dispersed throughout the world as possible, that's, that's what's [00:54:00] going to drive my decision. In

Mike: Lou, people are listening to this and they've got a couple of minutes to spare once they park their car , where are they going to learn more about your company?

Lew : Well, our sticker symbol is ITS Intensity Therapeutics. Our website is www.intensity therapeutics.com. You can google me Lou Bender Intensity Therapeutics. You can do a million ways to find us, 

Mike: Well, golly Lou, thanks for joining us. It's fun talking to you with your enthusiasm for this, because I know that investors are looking for the profit, not necessarily the reason, but it's cool to You've got the reason behind it and you've got the business chops

so really cool talking to you. Lou, I know you're busy. Thanks for your time. I appreciate it. The listeners appreciate it. It's going to be fun following you guys. So 

congratulations and look forward to keeping in touch.

Lew : Thank you, Mike. Any chance I [00:55:00] get to talk about what we do and to talk about the science of not just our science or whatever we talked about or the Wright Brothers, whatever. I love to do it. I appreciate the microphone 

Mike: Thanks Lou. Talk to you soon. 

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