Business Of Biotech

BoB In South Florida: Daniel Teper, NAYA Therapeutics

• Ben Comer • Episode 275

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In this week's episode of the Business of Biotech -- part two in a four-part series recorded in-person at Catalyst Pharmaceuticals' Miami headquarters -- we're speaking with Daniel Teper, an entrepreneur and most recently, founder and CEO at NAYA Therapeutics. Based in South Florida, NAYA is developing NK-engaging bifunctional antibodies and Astatine-211 radiopharmaceuticals targeting hepatocellular carcinoma. Daniel discusses the company's decentralized manufacturing strategy, the current funding climate for early-stage companies, his plan to conduct clinical trials in China, and what's unique about the South Florida life sciences ecosystem.  

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Ben Comer:

Welcome back to the Business of Biotech. I'm your host, Ben Comer, Chief Editor at Life Science Leader, and today we're in beautiful Miami, Florida for a series of episodes recorded on location at the offices of Catalyst Pharmaceuticals. For this series, we're speaking with some of the people operating companies regionally here in the Sunshine State, and I'm excited to speak with Daniel Temper, founder and CEO at NAYA Therapeutics, a company developing cancer therapies based on alpha-emitting radio pharmaceuticals and bifunctional antibodies, two very hot modalities in drug development today. Daniel has a diverse range of experiences in the life sciences industry, spanning commercial and operational functions, advertising and consulting, finance and company founding. NAYA therapeutics is the latest company he's founded. He's founded several. And I'm pleased to have him on the show today to learn about NAYA Therapeutics, its founding in 2023, what key opportunities exist in radio pharmaceuticals and bifunctional antibodies, and why he set up his company in South Florida. Thank you so much for being here, Daniel. Thank you, Ben. I mentioned your diverse background of experiences just now. You've worked in most, if not all, of the key functional areas required for biotech success. Why not simply go deep in a single functional area like commercialization, for example?

Daniel Teper:

Well, I think in order to be successful in biotech, you need to understand the translation from the science to the clinic to the patient. And this is something that I bring to my leadership, but that the entire leadership team of NIA also brings.

Ben Comer:

Having a diverse background of experiences.

Daniel Teper:

Having a diverse yet deep background in each of the functions and being able to integrate those different aspects. So of course, you know, science, particularly at early stages, uh, trumps everything. You need to have good science and good technology. Uh, but at the end of the day, you want to develop products that move the needle for patients and for physicians. Uh, so you have to constantly benchmark what you're doing and what you're developing to the patient needs and the competitive environment.

Ben Comer:

Right. Yeah. Um we at the business of biotech, we like to get to know our guests a little bit through uh learning about their background. And so I want to get to to Naya therapeutics, but I wonder if you could talk about a couple of experiences you've had prior to founding Naya that that taught you something important, maybe, or or served as a stepping stone to founding Naya in 2023.

Daniel Teper:

You know, I'd like to say that being an entrepreneur and even being a corporate leader is like competitive sports. Uh so you need to train a lot, but you also uh need to play a lot and you need to have victories and setbacks and learn from your setbacks so that you play better the next time.

Ben Comer:

Yeah. You've worked, uh you, you know, I mentioned you've worked in advertising, you've worked in in strategy and consulting, uh, you've you've had a number of different roles. Is there a is there a favorite that you've had? You know, leaving out uh company formation and company leadership, is there a is there a functional functional area uh that you particularly liked?

Daniel Teper:

Uh I like uh putting together companies and projects. Uh so the ability that I've developed over the years of taking different technologies, uh different products, and making it into something that's marketable.

Ben Comer:

Yeah.

Daniel Teper:

Uh that's one of my passion. And if you look at how we created uh NAYA and previous companies, it essentially is uh matching the vision to what is the reality, which technology do you need, which target, which cancer target are you going after, uh what disease you're prioritizing. When I was a strategy consultant, I did a lot of portfolio optimization for big pharma. And so which indication do you move first, and which you move second, and which you put aside. Uh and you don't have to make a decision once for all. You have to monitor is that is your data good enough? If it's not good enough, it's better to stop the project. Uh so constantly have a target product profile, which sometimes you know, scientists, in all due respect, they fall in love with the science.

Ben Comer:

Sure.

Daniel Teper:

And they don't realize that, you know, they have to match the target, match or exceed the target product profile, you know, constantly.

Ben Comer:

On that company formation piece, you you know, I mentioned in the intro you've formed uh multiple companies at this point. Is there a playbook now for you? You know, the a set number of things like you're you're and and maybe we can talk about it in the context of Naya. Um, you know, what what was the catalyst that led to that founding? And you know, what are the first things you do when you decide, all right, I'm gonna start up a new company?

Daniel Teper:

Yeah. I I I think the playbook is always evolving, you know, based on what you learn and the circumstances. Uh clearly what I've learned uh over the years is that uh timing is a critical success factor. Uh if you're too early with an idea or too late, you can't succeed. And I have to say, we'll get back to it is that with Naya, we have the perfect timing for what we're doing. And you know, some of it is luck, but the luck comes to those who are prepared.

Ben Comer:

Uh we're in Miami. Um, what are some of the reasons for headquartering, founding the company uh in this particular place?

Daniel Teper:

Well, this is not my first time in Miami. I've been back to Miami five years ago, but clearly the Miami uh of today is completely different than the Miami where I lived 15 years ago. Uh it's a bubbling uh metropolis. Uh, it is actually a world metropolis that is competing with New York and San Francisco and a number of uh European and Asian cities. And that's why you see people coming. You know, it's not just the gateway to South America, and South America is very important, but I think it's the gateway to uh to the world, and people are realizing that. And now we're getting to a critical mass of people that are coming from all horizons geographically, professions. Um, you have great physicians, you have great financiers, all in Miami. And that's a recipe for success.

Ben Comer:

Uh, you talked about timing in the formation of Naya. So I'm I'm curious. Let's let's talk let's dig into that a little bit. Um why was the time right in 2023 to found Naya? And was it because of you know the assets that you want to develop, you know, the the product candidates? Was that what made the timing right? Or was it something else? You know, what what came together and and spurred you on to start the company then?

Daniel Teper:

So I I think I will I will cover it from two angles.

Ben Comer:

Okay.

Daniel Teper:

Uh the the first one is when you're looking at the genesis of unicorn companies, typically those unicorn companies have two attributes is that they scale at the right time, so not too early. They know that there's a market need, they know that they have a technology that works and that can match the uh the market need. And that's true not only in biotech, that's true across industry. And then validated that that technology and that science you know works. Uh, if you do it too late, if you procrastinate on the science and you want to have more data, you can also fail because in the meantime, you know, you have 10 and 100 uh companies competing. I think one of the examples is the the PD1 VGF antibodies, which is a project that we considered. Uh, and at the time we considered it, uh, we had the right technology internally. We were force of fifths, and we got a chance to differentiate. And then within months, there were 153 and probably more today competitors. So obviously we put it to the side.

Ben Comer:

Are we getting to that point with GLP1, do you think? Or has it become so crowded in that space? Everybody seems to want to have one. I'm just curious about your thought on that, on timing-wise.

Daniel Teper:

So so it's all in the nuances. And you know, I'll I'll talk about GLP1, but uh also about our assets. Is if you're developing last generation GLP1, for sure, you're not competitive. If you're developing an oral one and you have a technology that works, that's a different story. And you know, I'm I'm oversimplifying, but that's the big idea. The same thing is true for the assets at NIA. You know, some of the investors are telling us, oh, it is competitive. And you say, what does it mean it's competitive? Is there still an unmet medical need? And if there's an unmet medical need, like there is an hepatocellular carcinoma, our lead indications, where over 75% of the patients are not responding to standard of care and or you know, relapse. And if you have half a dozen products in development, but the different modalities and different targets, and that you can be, you know, either first in class or best in class, or you have a realistic shot at getting there, then it's worth going.

Ben Comer:

Right. Let's talk about those assets uh at Naya um a little bit more. Um where well, I guess first off, where did they come from? Where did you get them?

Daniel Teper:

So the the theory that I was giving you, we we did actually put it into practice.

Ben Comer:

Okay.

Daniel Teper:

Uh so if we're talking about the bifunctional antibodies, we uh sourced the bifunctional technology scaffold from one of our founding uh scientists.

Ben Comer:

Oh, okay, so it's internal.

Daniel Teper:

Uh it's not totally internal. He did it in an academic setting, but we basically bought his rights to uh to the technology. Uh we identified uh epatocellular carcinoma and GPC3 as um epitocellular carcinoma is an unmet medical need. GPC3 has a great target. Actually, GPC3 is probably today one of the very best targets for cell tumors. It's an oncophido protein, it's expressed only on tumor cells, on liver tumor cells, uh, and and and a few other cancers, but it's really on the tumor cells and not on the healthy tissues. So that's that's a great target, and it it has also a pharmacological uh effect by itself. Now, the the other component of creating the the bifunctional antibody is what do we do to accelerate the killing of the cells. I mean it's accelerate and sustain the the killing. And immune cells can be redirected to kill the tumor cells, and you can do it with T cells, you can do it with NK cells. Um T cells have been more successful, but uh activating T cells also has significant side effects and and is is more difficult to use. NK cells, I would say the first generation of NK cell engagers has been disappointing because uh it didn't have a sustained effect. So we looked at the biology, we identified NKP46 as an activator of NK cells, which is consistently expressed in the tumor microenvironment, including in solid tumors, and that does serial killing, that reverse the dysfunction of immune cells. I mean, all those nuances of the science, you marry them to what are you trying to achieve clinically? And what you achieve clinically determines what's the market potential for your product.

Ben Comer:

Right. What about the radionuclide that you're developing? Is that a separate asset or are they working together in combination? How does that look?

Daniel Teper:

It's a synergistic asset. Okay. So it's not the same asset. Right. And obviously, we have backgrounds in antibodies. And in order to deliver radionuclides, you need a vector, and antibodies and particularly antibody fragments are particularly uh are appropriate. Uh the story that's interesting is that the scientists, you know, our scientists that helped us with the bifunctional antibodies also worked in radio pharmaceuticals 25 years ago. Wow. And even took a product to phase two clinic successfully to clean to phase two clinical trials. So when he suggested to me that there are some new radionuclides that we should consider that will help uh democratize the field. I, you know, I was all ears and the team was all ears, and and I would say within a few months we were able to create new products. And remember that we have a bifunctional antibody for HCC that targets GPC3. GPC3 is also a great target for radiopharmaceuticals. Actually, Bayer and Bristol Meyer Squibb are developing GPC3 actinium 225 radiopharmaceuticals, they're in phase one development, and obviously there's a reason why they they move they're investing in there. So we said if we take our GPC-3 antibody, we uh define the optimal construct, and for radiopharmaceutical, a fragment is a better construct because it aligns with the half-life of the radionuclide. Uh, and we have the optimal you know, linker and we have the optimal uh radionuclide. And the optimal radionuclide uh we believe is acetine-211. And why is it optimal? Uh it is very clean. It's clean for manufacturing, it's clean at the clinical level. What do you mean by clean? You know, radio uh radioactivity obviously um can be dangerous. Sure. You have radioactive waste.

Ben Comer:

Absolutely, yeah.

Daniel Teper:

You have toxicity, you know, you have to shield uh the units where you're treating the patients with most of the uh, I would say legacy radionuclides. Um if it has too long of a half-life, uh obviously you need uh you have a risk of bone marrow toxicity or kidney toxicity. So acetine-211 uh has been around for uh more than 20 years. Uh acetine-211 is could be the Goldilocks of uh of radionuclides. It has a short half-life, 7.2 hours. It has a clean decay, which you know, with a single daughter, which means that you don't have all the problems in uh in the waste, you know, in the waste management. Um it requires much less protection than the other radionuclide. And it's been proven preclinically and in early clinical trials to work just as well, you know, very precisely killing the tumor and particularly killing the isolated cells. I think what we forget often is that it's not all about bulky tumors and surgery and chemotherapy and immunotherapy. It's also about residual disease and metastasis. Um, if you take prostate cancer, which is not an indication that we're uh pursuing now, you can remove the prostate with surgery. But there's still you have a risk of relapse. And what's the risk of relapse is that you have isolated cells that are silent. And so that's where uh radiopharmaceuticals are very effective. And sure you're familiar with Pluvicto from Novartis. So it's using a beta emitter, which is more difficult, more toxic. Uh, so the next generations are the alpha emit emitters, which are ectinium, lead, and astatine. And we believe that astatine is going to be the winner. There's a room for all three, but astatine is gonna be the winner in the next 10 years.

Ben Comer:

So astatine 211, uh, you have that candidate. You have your NK bifunctional uh antibody, and you say they're synergistic, and you're developing them both for the same indication, but are they administered separately uh in concert with each other?

Daniel Teper:

So astatine is not a product. Astatine is a component of the radiopharmaceutical So you have one product which is GPC3 NKP46, it redirects NK cell to kill the tumor cells.

Ben Comer:

Okay.

Daniel Teper:

It is positioned in non-responders to immunotherapy and particularly to checkpoint inhibitors plus or minus a VGEF inhibitor like a VASTIN. Uh that's a huge market. That's 75% of the patients that are treated with drug therapy. Um the second product is GPC3 linked to astatine 211. So that's a radiopharmaceutical. I see. Its use is slightly different. So, first of all, it's very appropriate to use it uh in the half of the patients that are not getting drug therapy, they're getting surgery, ablation, uh, taste. Uh, and that what what you need, you need uh uh radiopharmaceuticals around those procedures before or after to eliminate the isolated cells and to minimize the risk of metastasis. Now, later in the treatments, either after checkpoint inhibitors or after the GPC3 NK engager, you can also treat, do a short course of uh of GPC3 astatine just to make sure that you're uh you're proactively handling the risk of metastasis. And there's even, you know, I want to I want to mention because I just read it yesterday, there's some early experiments of uh of radiopharmaceuticals in uh in lever metastasis. So you can get lever metastasis from breast cancer and other tumors. So that's more on the explorational side, but that's again uh a huge unmet medical need.

Ben Comer:

Um there's obviously a lot of excitement about radio pharmaceuticals. Generally, some really big deals uh have happened in that space. Um there's a lot of excitement about alpha emitters uh in particular, as you've mentioned. Um, in the past, supply chain, isotope half-life have have added a layer of complexity to supply chain manufacturing commercialization. Um, what can you tell me about, I guess, Naya's approach to sourcing uh astatine 211 and um and how you're scaling up manufacturing?

Daniel Teper:

Sure. Uh so until I would say the last few months, astatine 211 was restricted to just a few academic centers, two or three in the US, two or three in Europe, Japan uh was relatively more advanced in terms of the infrastructure because you needed to have the cyclotron, the radiochemistry lab, and the patient in the same location.

Ben Comer:

Okay.

Daniel Teper:

So that's that's very restrictive.

Ben Comer:

Right.

Daniel Teper:

Uh and what changed uh what changed this year, and that's where you know having all the stars aligned is extremely important, is that the Atlas E100 machine from Atlas Solutions in Sweden uh was was released, and that machine allows for automated purification, conjugation, and production of therapeutic dose um locally. So essentially, without getting into much detail, uh the the way uh our products are uh are being manufactured and will be manufactured in the future, is that you need a central or regional cyclotron where you're bombarded bombarding bismuth with alpha particle, and that gives you astatine powder on a target, and that target can travel easily and can be shipped to a local um lab uh where you can do the GMP therapeutic dose. So that local lab can be in Miami, can be in New York, can be in San Francisco.

Ben Comer:

Okay.

Daniel Teper:

Uh Bismuth, by the way, is widely abundant, right? And it's very inexpensive. That's a big contrast with what we're seeing with the other radioisotope that you know requires source of uranium or nuclear waste. So that's that's a big difference. So our vision is essentially that uh they will be uh five or six uh commercial regional cyclotrons, and we have a partnership with Ionetics uh currently based in Michigan, but they have plans to expand. There are other companies also doing that. Um and then you will have multiple decentralized GMP micromanufacturing units, which are not capital intensive. And I would say for the US, it's probably between 10 and 20, depending on the coverage that you want.

Ben Comer:

Okay. Uh that's excellent. I I appreciate that. I I want to um ask about Naya's uh current financial situation and runway, but really I guess what I'm looking for is um what the current investor situation is like for you know a company that's in the early stages developing some really novel products. You know, what's what's your read on the investor situation right now? And do you think it's improving or or not?

Daniel Teper:

I think after the summer, uh the investors are looking for opportunities. And the reason they're looking for opportunities is because they see the constant appetite of uh pharma companies uh for novel biotech. I think it's up to 75% of the products are being sourced uh from biotech companies.

Ben Comer:

Yeah, right.

Daniel Teper:

Now they're being sourced uh earlier and earlier. This is something that I always like to illustrate. Uh the 304 transactions in radio pharmaceuticals are phase one, phase two at the latest, sometimes even you know, pre-clinical.

Ben Comer:

A couple of those are billion-dollar transactions.

Daniel Teper:

They're multi-billion dollars. So I like to say that you know, the some of the best transactions, whether it's bifunctional antibody, by the way, or radio pharmaceuticals, they're one to four billion dollars, I would say, in phase one, two. And once you get into phase two, three, it's five to ten billion. I mean, we just saw this week uh GenMab, which is not a big pharma, it's uh it's a large biotech acquiring mirrors, which is in phase two, three for eight billion dollars.

Ben Comer:

Yeah.

Daniel Teper:

So obviously that's attractive for investors because investors today are looking for exit in the relatively short term. So I would say on on average, and and and we do the same. So we're saying if there's not an exit, an exit can be without licensing, it could be an MA, it could be an IPO. So if you don't have an inflection point that justifies an exit strategy within two years, then it's much less investable. Uh so in in that context, NIA has a pipeline with clinical infection inflection points that support an exit. And again, it doesn't mean selling necessarily the company. It could be just out-licensing one or two products or doing an IPO within the next uh the next two years. So in uh we uh we're currently raising series A of $75 million uh with institutional investors. Uh this is you know in the range of the transaction, the high quality transaction that uh have been announced in the last uh few months, and that uh that covers actually the execution uh of the development uh up to uh clinical data.

Ben Comer:

So, what is your um from a I guess a clinical perspective, what is the milestone that's your top priority for the company right now? What what's next for the the two assets that you're developing?

Daniel Teper:

So we are starting to treat patients um in the first half of 2026 for the bifunctional antibody, and in the second half for the uh the GPC3 uh astatine uh radioform. Uh because of the nature of oncology, those those trials are uh uh are open and you get data as you go. So we anticipate that in early 2027 we'll have initial data, actually potentially on both of them. And by the end of 2027, we'll have more comprehensive data. The number of transactions that with only 30 patients have sparked the interest of um of pharma companies. So we want to be funded sufficiently so that we can progress on our own, but obviously we're open to you know partnering with pharma to accelerate. Uh, we're also you know quite agile. So I'll give you an example. Uh we're considering doing the initial uh clinical trial for the astatine product in China. Oh, interesting. Uh and the reason of China is that you can do investigator-initiated trials faster than you can get an IND. Uh, HCC is extremely prevalent in China. So you can recruit 20, 30 patients within a few months, and you can get substantial data.

Ben Comer:

Now, that would be you would have to anonymize that data to bring it back to the US, right? Or would you be doing that um in an effort to commercialize in in China eventually?

Daniel Teper:

So eventually we want to commercialize in China or whoever our partner is would commercialize in China and it it's a huge market. But I'm sure uh I mean everybody is talking about all the deals that are sourced from China. Yeah. Uh and whether it's pharma companies or VCs, unfortunately for us, they're sourcing deals in China.

Ben Comer:

Right.

Daniel Teper:

So the question is as an American company, can we be smarter and take advantage of the infrastructure in China to get data sooner?

Ben Comer:

Yeah.

Daniel Teper:

And and we believe we can do that. Uh, we have a partnership that uh we're planning to announce you know shortly with a company that has capabilities for GMP manufacturing in China. In China of astatine products. Wow. Uh which actually that's a company that was started by uh two very renowned academic scientists from the US. So you have more and more you know movements. Uh the the word is you know is not isolated. So you it's coming from the US to China, from China to the US. I think India in the future will also you know rise. Um so anyway, moving faster, being lean. Not spending money for the sake of spending money, uh, putting the standards very high in the execution, but making sure that every dollar that we invest in development matters and gets us closer to clinical data?

Ben Comer:

I want to ask a question for the listeners of the business of biotech, many of whom are at very early stage preclinical companies or even thinking of starting a company. What case would you make to them about setting up their company in Miami? And what is some advice you would give to maybe a first-time company leader?

Daniel Teper:

I would definitely, and I am recommending uh uh entrepreneurs to move to Miami. It's a very unique environment. Uh you know, some of the other ecosystems are very mature, uh, they're very crowded. Uh Miami is rising, it's not crowded, it's entrepreneurial, everybody wants to work together. Uh, you have easily access to key opinion leaders, you have easily access to investors, including institutional investors and and bankers. And you know, it's it's it's like uh immigrants moving to a new territory and wanting to build something together. And so that's a unique environment that I don't think there's any other place in the US that an entrepreneur can find that.

Ben Comer:

Final question, and I'm asking this of everyone that I'm speaking with uh while I'm down here in Miami. Uh it's a hypothetical, which is let's assume you find yourself in the predicted path of a category four or category five hurricane. Do you board everything up and honker down, or do you pack up the car uh and get out?

Daniel Teper:

Are you talking about personal or for the company? Personal. Um I've been through hurricanes in the past, being in Miami. And um I I would say stay here. There are risks everywhere in the world. There are risk in California, there's even risk in New York City that uh you know water we submerge Manhattan.

Ben Comer:

Right.

Daniel Teper:

Uh there's unfortunately, you know, risks of war. Uh so I don't think there's more risk in Miami than any other place.

Ben Comer:

All right, we're two for two on stay in town and hunker down during the hurricane. Uh, thank you so much for speaking with me, Daniel. Uh, we've been speaking with Daniel Tepper, founder and CEO at Naya Therapeutics. I'm Ben Comer, and you've just listened to the Business of Biotech. Find us and subscribe anywhere you listen to podcasts, and be sure to check out our new weekly video cast of these conversations every Monday under the Business of Biotech tab at lifescienceleader.com. We'll see you next week, and thanks as always for listening.

Daniel Teper:

Thank you, Ben.

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