Great Negotiation Means Everyone Wins | Arun Swaminathan, MM, PhD Pharm. Sci. Coya Therapeutics, CEO, Board Member

Mike Koelzer: Arun, introduce yourself to our listeners.

Arun Swaminathan: I'm Arun Swaminathan. I'm currently the CEO of Coya Therapeutics. I come with a background in biotech and pharmaceutical. All the way from being an undergrad pharmacy major to a PhD in clinical pharmacology. I grew up at Bristol Myers Squibb, initially designing clinical trials, but then moved more to the business side of things pretty early in my career.

BD licensing, marketing. and then the last 10 years I've been more in business roles, mainly in the C-suite, of small public companies and one private company that I co-founded, similar to Koya.

Mike Koelzer: Alright, Arun, when I look through your LinkedIn, one word pops out at me and it's a deal. Like, I made a deal with this. We made a deal with that. What do you mean by deal? I was kinda reading it. I didn't know if you sold your company or bought a company, and there's some huge numbers in there.

So when you hear the word deal from me asking about you, what does that bring to mind?

Arun Swaminathan: deal to me in this context is pharmaceutical strategic partnerships. That is what we mean by a deal. That is something I have executed quite a bit on in the last 10 years. Basically it is ways. To strike partnerships with bigger pharmaceutical companies as a smaller biotech that allows each of these companies, including koya, to get.

Financing and money in a non-dilutive manner, meaning not in the typical manner where we give equity in exchange for money, but entering into strategic partnerships that allow us to move our programs forward, without necessarily, raising money in the capital market. 

Partnerships that are truly strategic and not transactional. It means partnerships with companies where there are synergies, where we're able to leverage each other's strengths to make the products better, and more importantly, to bring these products to the patients that are waiting for it faster. 

Mike Koelzer: sometimes deals have bad

loses, and it's,

One team does this and then they're out and the other people step in. But this is a deal of say, let's synergize this and how can we move forward as two or more companies using each other's strengths and so on.

Arun Swaminathan: Exactly, strategic partnerships are different from a transactional deal. These are by definition, strategic where both parties are mutually gaining and both parties bring to the table different strips. The bigger companies bring to us their footprint, their ability to commercialize.

They're sales forces and we bring our scientific innovations, our ability to be nimble, ability to move forward. And these are good marriages essentially. Maybe we should call them deals, we should call them strategic marriages.

Mike Koelzer: You say these aren't transactional at their core, but it's not just like, Hey, Fred, how about you help us out and we'll help you out. There's obviously some incentives. there's some stock, there's something there.

What kind of things are there that would be different than just saying, we bought you out, or, you know, you sold to us? What kind of things are there that are transactional but not to the point of.

Arun Swaminathan: Yeah. No, Mike, that's true. Of course there are. incentives for both parties to enter into this kind of a marriage, right? and those incentives usually are financial. For example, we have a partnership with Dr. Reddy's, a $13 billion multinational company headquartered out of India, but they're a multinational company.

We have a partnership with them where they will commercialize our product. Goya 3 0 2. In one indication, which is Atrophic Lateral Sclerosis, A LS Lou Gehrig's Disease. What is transactional about it is very straightforward. In exchange for their partnership with us, they gave us upfront cash that allows us to complete the trial we plan to complete next in a LS.

So it gives us the funding to do that trial. It'll also give us funding on a milestone basis. As we hit milestones, we are eligible to receive payments from them again in a non-dilutive manner, meaning no shares are exchanged. what is it they are getting is your question?

What does Dr. Reddy get? Is the right to commercialize this product in most of the global markets. So they get to book the sales, they get to keep the sales, and in exchange they give us a fixed percentage of royalty, which in our case, in this specific deal, is mid-teen royalties on their sales.

So they get to keep. 80 plus percent of the sales for themselves while we get to 15, uh, whatever mid-teen percentage, on a steady basis, without us spending money to commercialize. So it's kind of a win-win for both parties. Now, there's two schools of thought in negotiations and transactions.

Mike, I clearly fell. In the category of people that believe transactions need to be win, win. Now there are professionals, there are professional negotiators that will say it's win lose, meaning somebody's gotta win. and it's gotta be me. I completely disagree with that approach, especially in our industry.

We are not. People that are just trying to say, how can I do something that I get what I want but the other doesn't? No. This is about doing things where both parties are gaining something. What we gain in a relationship with Dr. Reds is. Just from a financial perspective, what we gain is the ability to get us funded where we can move forward without the pressures of having to constantly raise money.

What they get is in the backend for their investment. They could have a product that makes billions of dollars a year, and then at that point we continue to get a significant amount of money from that deal. But more importantly, what we get right now. Is support from a bigger company on the regulatory aspects of it.

On scaling up of the manufacturing, supporting our manufacturing, building up a commercial sales force. The biggest challenge small biotech companies have is. Okay, I've got a great product now I've got FDA approval. Now I need a sales force. I need to spend a lot of money commercializing it. We have taken that risk off the table for koya, right?

That's what I mean by a win-win deal is yes, we're each giving up something, but what we're giving up is for us. Actually upside, meaning it is something that is building on our core competency while we are giving something else to somebody who can do it better than us. 

We're giving them innovative science. We are giving them our ability to know how to design trials in neurodegenerative diseases, our expertise in this therapeutic area, right? So we bring to each other complimentary things and yes, we're both hopefully going to financially gain from this partnership as well.

Mike Koelzer: Do you ever watch Pawn Stars?

Arun Swaminathan: I have never watched it, Mike, but I do know what the story is. I think people go in and bargain for antiques and yeah, I kind of conceptually know what it is. 

Mike Koelzer: a pawn shop, and it's not true to life They always bring in an expert.

Arun Swaminathan: Yeah.

Mike Koelzer: I've got this old book expert around the corner. Do you mind if I bring them in and they look at it and decide on the pricing and so on. What I like about that show is for the average person. The average person doesn't do much negotiating. And the only negotiating we have in our head is like negotiating with a used car salesman. That's like the only thing we have where one side has more information and you know, you feel like you don't know what direction to go in because your other car's on the fritz and you kind of need to make the deal.

And that's like the only. negotiation, I think a lot of us have. But I like the Pawn Stars thing because they go in and the guy's like, you know, 500 and the other guy's like, you know, 2000 and they say, well, 800. And they say, you know, 1800 and they're a thousand bucks apart. And they just say, well, we're too far apart.

And they shake hands and they're joking and laughing and that's the end of it, you know, and, It's fun to watch. 'cause not enough people see that when negotiations they don't have to be adversarial.

they don't have to win or lose, you do enough of it. There doesn't have to be a winner and a loser. It's like we can both walk out winners.

Arun Swaminathan: Exactly, and maybe I should watch this show now. You've intrigued my interest in it. You might have acquired one new viewership. Here. To be candid. I don't believe anybody who tells me they negotiated where they got everything they wanted and the other side got nothing they wanted.

'cause there's something fundamentally wrong with that because that doesn't sound credible. I would challenge those people to show me that they actually did that. All negotiations are a rational discussion around how we can create value. For each other, how do we together create more value than alone?

That is what the negotiations that I'm involved in are. It's about how we create value together. If you have that book expert that is looking at an old book and saying, guys, did you know that this book is so unique because of the type print they used? And therefore it makes it more valuable that partnership together just increases the value of that book. It's the same thing with formal partnerships together. How do we increase the value? How do we increase the probability that our product is going to make it to the patients that are waiting? How do we make together increase the sales potential? How do we, together, Expand the science and advance the science?

It's a question of where. Our needs are and where their needs are, and where we are able to find an intersection that kind of is a sweet spot where both our needs align, to solve two people's problems, so that's what I do. That is what I focus on. 

Mike Koelzer: There's a book. I think it's The Wizard of Ads by Jay Levinson, and he's an old marketing guy, just little snippets of his wisdom One of 'em, he was talking about negotiation, he was negotiating with somebody for a boat or something like that.

And they got done and there was, let's say it was $5,000. And at the very end of it, the other side said, need you to throw in another $500, And this guy says, well, no, we already struck the deal. And the other guy says, well, do you blame me?

and the author said, yeah, I blame you. If you wanna squeeze every drop out of something in each negotiation, go ahead. But if you want to have some symbiotics. growth and all that kind of stuff. Yes, I do blame you. we need to, give and take.

We need to show that we're not gonna pull a fast one on somebody. All that kind of stuff. It all builds up and there's no such thing as a one time in these days because you're negotiating with someone now and A year later, you might negotiate with another company, but guess what? The guy on the other side of the table is now with that company 

So there's no such thing as a one and done when it comes to you gotta keep those relationships going.

Arun Swaminathan: A hundred percent. Mike, you nailed it. These are relationships. These are marriages. You have to build for the long term. You have to build trust, you have to build credibility. 'cause nothing is going to make this partnership more successful than those elements. this is not your previous example, used car I.

Purchase, right? Where it's purely transactional I'm never gonna see that guy again in my life. I buy my car and I leave. So yes, I can keep asking for as low a price as I want because I have nothing to lose. There's no relationship I'm trying to build with that salesman. But this is not that kind of a transaction.

These are true. Partnerships and like any partnership, if you only focus on what I am immediately, how do I maximum get what I want right now, as opposed to losing and losing sight of the long term and the midterm, you are gonna lose the relationship and you're gonna not. Create value. I'm gonna go back to the whole point of these partnerships: one plus one is three and it's not two.

So that is what we have to build towards. And I truly believe that all of these partnerships we have struck not only with Koya, but in my previous companies, that is exactly what we did, is we created. synergistic relationship, yes. Where both parties have something to gain obviously, but both parties collectively are gaining too, and that's the nuance of a good negotiation, a good strategic partnership.

Mike Koelzer: Arun, I've got some advice for you and the listeners might take something out of this too, but we talk about one and done. I alluded to the, uh, used car sales person. So about 20 years ago, we bought my daughter a car and I had enough of the car lots at that time. So we pull up to this guy's house and he's got this, it wasn't a Jeep, but a little. Kind of like a car. And the guy's like, I've got 13 children and I do this for a hobby and, you know, sell these cars. So we pull up to this car and he puts the dipstick in. Pull it out and it's got just this nice golden oil on it. And he wipes it on the back of his hand to wipe off the dipstick, and I thought to myself. This guy wipes the oil off on the back of his hand, almost like he's presenting you with an expensive bottle of wine.

So I'm like, ah, he must know what the hell he's doing. I'm gonna buy the car from him. the fact that it had this little, little chug about every 30 seconds, and I thought. What about that? And he's like, ah, that's nothing. We get it home and a week later we find out the whole engine is shot and the repair is about the same cost as the car, you know, $4,000 or something like that. That's an example of one. And done. And Arun, that's a free one for you. If you ever go buy a car and the guy wipes off the golden oil on the back of his hand and presents it like a bottle of wine, just. Run.

Arun Swaminathan: You started this conversation by asking me what is a deal now you made me think about it. Maybe that term deal has, it's not the right term in pharmaceutical partnerships. I think it's a strategic partnership that comes with terms and conditions.

Mike Koelzer: I still like the word still. I like that because You hear a lot about and it seems like, you look years later and the partnership's not there anymore for whatever the reason, you know, it's like, yeah, that really

Arun Swaminathan: Yeah.

Mike Koelzer: I kind of like the deal because it admits upfront that. Yes, we're a partnership, but we're also a corporation and our main goal for us and the shareholders is. Maybe to do good, but you do good by having enough profit to do good. So I'm going to say we're gonna leave a deal on your LinkedIn, Arun, that's gonna stay there. We need a good deal, but we need someone like you who understands both sides of the deal and what it takes to make a successful deal.

Arun Swaminathan: Well, you have a deal, Mike.

Mike Koelzer: So Arun, what is the structure of Koya though, as far as, who owns it? Is there stock? Is there a board?

Arun Swaminathan: Koya. We're a public company, so who owns us? The public owns us. Our investor owns us. That's the simple answer. We have a mix of investors. We have our lead investor Greenlight Capital. With about 9.9% stake. That's David Einhorn. We have other biotech funds like A IGH that own upwards of 8%.

We have our founder. Former CEO and current executive chairman Howard Berman, who owns a significant percentage of the company as well. And as you probably know, Mike, in public companies, the disclosure rules are 5%. So people who own over 5% of our company, we know who they are because they have to publicly disclose it.

But there are others like that. Own our company that we may know, but we don't publicly know. So there's a lot of people who, anybody can buy, and take a position in koya by buying our stock. It is, COYA. so we do have a mix. We have Vanguard group that has, I believe, over 5% as well.

Those are the public disclosures. and then there are other investors that don't cross that 5% threshold, so they're not publicly disclosed. Therefore, even if I know who they are, I refrain from publicly sharing who they are. It changes hands every time somebody buys and sells stocks. Our ownership is changing hands in a small way as well.

The rest is that sometimes people use the term retail owned, which means people like you, people like me, people like others are buying shares in Koya. The management team, including myself, have ourselves taken positions in Koya. So we also have an Ownership position in koya as well.

And as a public company, of course, we do have a board. It is important that we have an independent board. We have a stellar independent board. Our board consists of, spectrum of highly accomplished people, ranging from former CEOs of big companies. To former Secretary of Commerce for the United States, to people who have led R and d organizations at big companies, to people who are leading r and d organizations at their current companies.

manufacturing experts, finance experts. We have CFOs on our board, so the board, as in any of these companies, comprises people who have accomplished a lot on their own in their careers and bring to the table expertise that can help guide the CEO, which is me and guide. The management team as well to make sure we're making the right decisions.

be the checkpoint, be that, balance as well to make sure we are doing what is in the best interest of patients, shareholders, and the community as a whole.

Mike Koelzer: Here's what I want to ask. I wanna ask if I knew who the board members were. Would you still have them? That's kind of how I wanna ask that. But I'm gonna soften it a bit because let's say the board happens to listen to this. how much of a board is having the best thinkers, even if they were anonymous people who have had success, maybe even if it doesn't really relate to your success or you can't find that correlation and how much of is it kind of advertising to potential investors, whether it's single stock buyers and things like that, or another 5% or higher investor come in, that kind of stuff. 

Arun Swaminathan: Yeah, no, it is a sensitive question for sure, Mike, but the short answer is. I would be proud to have the board I have, even if they were invisible to your point. Meaning even if we weren't able to publicly say which, which if we're a private company, for example, I would still be honored to have the board we have because of the value they bring to the company.

That is why we have the board members. Are there certain public Benefits of having people whose accomplishments are obvious to people when they read their resume. Of course, of course. And you know, that's true for management teams. Do people want to see a CEO of a company ?

Has no record of having done anything. Probably not. They may be brilliant and bright minds, but people like to see that people in charge, people who are making decisions, have a track record of having made decisions, have a track record of having been successful. Does that track record always guarantee that they're going to do the same?

Success in their new roles? Maybe, maybe not, but I think, if you're going to evaluate risk, which is what we all do all the time, I would rather bet on someone who has got a track record than somebody who is not. I would rather recruit. A player that has shown me they can score the winning touchdown, then not, right?

I mean, will they do that again in their next level? I don't know. But the short answer to your question is that, our board members, I would, in a heartbeat have the same board members, even if they had to be invisible.

Mike Koelzer: You bring that up, you can think of Tom Brady or something like that on paper. What was his sixth round draft pick? But he did something. He's a winner somehow. Or , I always think of actors, like, how did that actor get there?

And then you think about their acting chops and you're like. they may be all equal, but he had something, and it's hard to say exactly what it was, the point is, someone who is known by the public. In addition to being successful, somehow they've risen a little bit above that top. You don't know what it is exactly. It's something inside of them. it's some form of, of championship. It's something there and it's like, well, what the hell? If I've got a choice of five people and they're all the same on paper, but this one's risen up, and then people know him or her because they've risen up.

Arun Swaminathan: Of course I'm gonna get them over somebody else. Not always, you know, there. I think, uh, hiring not always, you know, I think, uh, sometimes you're looking for people that are hungry, that

got the talent, that have the drive that haven't yet achieved those things, but they have it. And, you know, being able to recognize that. And bringing some of those people on board is part of leadership traits.

Make some people good at identifying talent. Again, since we're talking sports similar to sports, the scouts that recognize talent early, Those are not talents that have already accomplished anything. It's talent that you see and say, you know, here's an individual that I think. In my environment, my company is going to succeed and thrive.

Similar to sports teams. There's also that fit and match that has to matter. A star in another team may not be a star on A different team because the dynamics, the culture, the work ethic that works for one company may not work for the other. So in the corporate world, I find the same. It is an art as much as a science.

That's why I think, there's a whole industry on leadership and, fighting talent and growing talent and my God, that's a. Multi-billion dollar industry right now, I would presume. And nobody has solved the problem, there isn't one template. 

if there was one clear philosophical answer, by now everybody would know it. The reason is we don't know why we exist so many books are written on leadership.

So many books are written on how to attract the best talent, how to retain the best talent, because there isn't one template. If there was one magical path and answer. We would all be following it. There's a lot of intuition. There's a lot of luck. There's a lot of timing.

There's a lot of things that go into, I think you said it well, those intangibles that none of us can really parse out. We can't say, why did this work? Or why did this person. Get something done that the other person couldn't get done. we don't know. It's a lot of times in retrospect, just like Monday morning quarterbacking, we can probably say what they did right.

But we are not good at being able to predict it. it's, and people who try to. I mean, they try and there's a science to it. There's an art to it, but it's obviously, as I always say, if there was a template that we could all follow for building a successful company, we would all do it. here you do, you do X, Y, and Z and I guarantee you it's going to be successful.

It doesn't work that way. That's where we all make our own impacts is in understanding how our microenvironments are different from the other companies. what applies for one company may not apply for Coia, but what applies for one company maybe I can learn from. it's hard to have a blanket, if I do this, we are gonna be successful.

Mike Koelzer: I'll use me as an example. 300 shows ago, five or six years ago, I kind of started the podcast. I wasn't sure how my business was going to do, and so I thought, I'll get my name out there a little bit, and now 300 shows later, not only has no one reached out to me for. advice or consulting or that I think they've kind of shied away from me because I'm the old fart. I'm the guy that says, we've tried that before and we're not going back, and I've just given it to people straight , I don't have to be an. Influencer or anything. So I'm an example of someone who has had moderate success in my independent pharmacy field.

You wouldn't want me on the board, I mean, maybe as a naysayer, you know, to put the ixy on some things. But to your point you have to have someone that's a little hungry for things.

Arun Swaminathan: To your point, in a company like Coia, it may not be true in bigger companies. I have repeatedly said this, the kind of DNA we need in koya is the DNA of people that are problem solvers, not problem identifiers because,

We do have to identify the problems, don't get me wrong, but the wiring we look for is people who say, I get it.

I've identified these problems. Here is how I think we can solve for it. Koya cannot afford to have a group of people, that is, we're a small company where we can't afford to have half of our people being problem identifiers. I'm oversimplifying, most of us are both, by the way, but I would rather have the people who are more prone to.

I'm gonna figure out how to solve this, and that is because we're still an entrepreneurially wired company. That's what we need. A 10,000 person company may need a different kind of skill set. They may need an equal number of problem identifiers.

You know what I mean? People who are saying, you can't do this, or this is gonna be. Very hard to do. Don't go there.

Bigger companies have failed at this.

I had a conversation with someone that worked for a contract organization.

The service that that company provided was very simple. They would help me or companies like us look through the risk of our portfolio and say. Don't advance these products, advance these products. Like meaning, they'll help you prioritize which ones to kill, for a lack of better word. And I recall having a one-on-one conversation with this person and I said to them, I like what you're doing.

And I liked the approach, but at that point I was with another small company and I said, but you understand. Our model is not, we have 20 products and we're trying to prioritize three. Our model is, we know we have four or five things that we're moving forward. I wanna see how to make them successful.

I'm not looking to make a decision on which one not to advance. So as much as what you're doing is exciting. It doesn't meet the needs of a company like ours. We are trying to see how we can advance what we have. How do we make what we have successful?

Mike Koelzer: Sometimes almost as bad as the person that points out the problem is the person that points out the, Idea, but with no way to get there. don't come to me with this suggestion unless you've got some way to move it forward.

well for sure, don't come to me with a problem if you don't have a solution. But don't even come to me with a suggestion unless, 

well. What would be the first step on that? Go right out three or four steps and let me know, there's people that point out problems and people that have ideas, but sometimes there's just no way to get there. 

Arun Swaminathan: Ideas are important but ideas without a plan of execution on how you are. Make that idea a reality. Usually they don't go anywhere. so you kind of need a combination of both.

come from free thinking. You gotta be able to think unconstrained. I'm a strong believer in the ability to think unconstrained because if you start thinking already with all the limitations in mind, sometimes you, 

Cut some good ideas off. But once you get those good ideas, I a hundred percent agree with you, Mike, is then you gotta say, what do I have to do to even test this idea first and then bring this idea to fruition, whatever that fruition may mean in the pharmaceutical industry.

 idea to a product sometimes takes. Eight years, 10 years. But what is the next step? What is my immediate six month goal where I will get enough of an indication that my idea is worth continuing to pursue? What will be those metrics? So now I have to get real about how those ideas can come to life, right?

My wife and I are going to move to our cottage in four years or so. you alluded to this, but I'm the same way. It's like, let's think big, but then let's just, bring it smaller down, but let's just let our mind wander. so we're gonna redo our kitchen up there with the island and put another room on and things like that. I said, Margaret, now I've got an idea. Now this is crazy, so bear with me. I just wanna say it. don't really picture us going there. She's like. Mike, you don't have to set all of these up. She said, I'm open to ideas. Just let me know. If it's not good, we don't do it. But you don't have to be afraid of me and say, Margaret, you know, don't, you don't have to do all that. Just tell me. So I said, okay. before I even got the whole word of the island out. only had the first syllable out. she said, no, wait a minute. You just told me I could have the idea. so you have to be open, but you've gotta live with reality too. 

Yeah.

Mike Koelzer: Arun on that board, with all that wisdom. I just had a guest last week, and we talked about the difference between, a managerial board, an idea board, just a yay, nay board. With all that wisdom, how does that work out? Do you tell the board your goals and they comment on it? Do they vote on it? do they put input in? With all that wisdom, how much do you want from them? How much do you get from them

Arun Swaminathan: So Mike, number one, it is a job of the management team to run the company. It's not the job of the board to run the company. The job of the board is to be what you want them to be, which is a sounding board. If you have ideas that you are trying to understand, before making a big decision, you want some smart people to also take a look at it.

The board is one of them. The board also plays the role of just. Making sure that the management team is executing against the objectives they set, right? We all set objectives saying this is what we wanna try and accomplish this year. So the board kind of plays that role also, for lack of a better term, keeping a scorecard on the management team, and making sure that everything is insured.

How much does a management team leverage the board? I'd say good management teams will leverage the board in a smart way because these are talented people. Reach out to them on their expertise, reach out to them. Somebody may be an expert in capital markets. Just because I'm the CEO doesn't mean that I have to work in a vacuum and not get their input. Is there something I could be doing better?

The board is complementary to what we do, but they're also independent. And the reason they need to be independent is to ensure that. They have the right to kind of step in and go, Hey, the management team is not moving this company in the direction that they thought that we were gonna move it.

And it's their job to make sure that they point it out if it's appropriate. but usually in a good performing company, that relationship Is very open,

very collaborative. and that's kind of how I view the board's role, they are an integral and important part of the company's success.

Mike Koelzer: So, Arun, regarding Koya, what is the direction over the next few years? We talked about partnerships and marriages and deals and things like that. Where is the company going? What do you hope for?

Arun Swaminathan: What we want to do, Mike, our vision is to make some of these diseases like ALS frontotemporal, dementia diseases that are. Livable meaning today, an average LS patient's lifespan is about three to five years after diagnosis, and in that three to five years, their quality of life deteriorates at a pretty rapid rate in many of the patients.

So our first vision. As if in the next five years we can get a product approved that allows these patients' disease not to progress, meaning it doesn't get any worse than where they were when they started the drug therapy. That would be a transformational win, not only for the patients, but for koya, for the community, for everybody.

 And I always say this, if you do what's right for the patient and deliver what's right for them, everything else that we are obligated to our shareholders for will come through. Meaning we will be profitable, we will have good sales. We will return shareholder value, everything will come because, you know, you are providing a solution for the end customer, which is the patient.

So that is what I want to see. Five years is. Coia being a company that has delivered a product. In our case, our lead product is Coia 3 0 2, and the lead disease is a LS. So ideally, I would love to see that we have an approved product for a LS that's in the market meeting, the high unmet need for these patients.

Mike Koelzer: So like you say, within five years of getting something on the market, I'm assuming that you and your investors probably have benchmarks like by this year you want to have phase one, phase two. These are pretty common benchmarks. I imagine. There's so many things you have to get through with the F-D-A D-E-A,, all that kind of stuff.

Arun Swaminathan: Exactly, I mean the good thing about biotech is that the process is well known, meaning you have to do certain things to get through the regulatory steps. To meet the regulatory thresholds for safety and efficacy to be approved and be in the market.

So, you know, we guide that publicly. For example, we have said that we will start, we anticipate starting the phase two B study in a LS. Later this year, in the second half of this year, subject to FDA Green light, we know exactly what we need to do, to what information we need to provide the FDA, we're aligned on it.

We plan to do that very soon in the next month or so. The steps are clear. FDA has clear guidelines. Uh, the FDA is very communicative in general with biotech companies. and then we move forward so our investors know when to more or less expect those events. And once you start a trial, it is not that difficult to predict when the trial's going to end within plus or minus months.

so we will do that and then people, our investors and others will also know when we can expect. Results from that trial, right? People can kind of know approximately when it's likely to come, and then once the results are there, how long does it take now to go back to the FDA?

Does it meet the criteria to get an approval? All that kind of stuff. The nice thing about the diseases that we are initially focused on is that they have a faster potential path than, say, a disease like diabetes, where there are many choices.

And what it takes now to show that a new diabetic agent is better than what currently exists, the bar is much higher and rightfully so. whereas with a disease like a LS where there is. Really not many options for patients today. They continue to decline and die in three to five years. 

The way the regulators look at it is also different, right? Regulators want the same thing. We want safe and efficacious drugs available to manage the unmet needs of patients. We all want the same thing. Yes, we as a company, our motives to bring that to the patient also means that we will hopefully be a profitable company, make money, all that stuff.

But for the FDA, their mandate is to make sure that whatever products are available. The market is safe and efficacious. That's why they exist. And That's true for Europe, Japan, any country, they all have their regulatory bodies who serve a very important purpose.

And in general, I find them pretty collaborative and smart in how they think about these things. People misunderstand, but I think everybody wants to see new and better drugs come to the market for patients. 

Mike Koelzer: What's the worst part of your week when you wake up and you look at your phone or planner and you're like, ah, crap, I gotta do that today. What is that for you? 

Arun Swaminathan: Nothing where I wake up and go, I don't want to do this today because I view my job as, especially as a CEO, that's the one thing I have, and I actually enjoy, as a CEO my calls, I don't have two same calls in a day. I'm doing this with you today. Right now. I just got off a call talking about high science before I came to you.

I will be on some call that decides what we do about renewal of our, you know, employment, be employee benefits on another call. And I like that aspect of my job. I like that there is that diversity in my day. My day is not just about my core competency and I'm in calls where. Honestly, I am the lowest expert on that call, but I'm also the decision maker on some of those calls.

So it is my job to kind of understand what that means. What does it mean? What am I really, so short answer is there isn't much that I can do to wake up and go. I wish I wasn't doing this today. Now as any of us are there are days when I wish I had a different kind of day. Sure. But, you know, that's part of running a company.As a CEO you sign up to be not just an expert in what you know, but you sign up. To make decisions on things you don't truly fully have expertise on. So then you come down to how do you learn to rely on experts, but learn to start asking those right questions that can tell you if there's some underlying problem that's kind of not coming up to the surface, so I actually, enjoy my day. It's partly my personality, partly the job, but I'm always on the simmer as I joke with my wife. I'm ready to ignite in one moment's notice, meaning I'm ready to come back fully on in one moment's notice, and that comes with the territory.

But, I enjoy it. it may not be for everyone, but I certainly enjoy it. 

Mike Koelzer: I tell that to my wife. I'm probably 2, 4, 5 years away from retirement. It's like you don't even know how much is on you. You talk about simmering. It's been like this for the last 35 years. Every Thursday, you know, I'm picking a day every Thursday at 2: 37 in the afternoon. That store has to be open. What does that entail? It means you have to have enough money. You have to have enough employees, you have to have the right inspections, you have to have heat. You have to have the light. I mean, there's a million things that have to be there, and we're used to it, it's on simmer, but there's a crap load of stuff there that never turns off. 

Arun, thanks for your time. Nice talking to you today. I appreciate you, letting us get into the business side of things.

I know there's a ton of medical stuff we could be talking about that I wouldn't know anything about, but I enjoy pecking around behind the scenes of Koya . So I appreciate your openness. I know you have a lot going on. I appreciate it. Our listeners appreciate your time and so thanks for joining us.

Arun Swaminathan: Thank you, Mike. Thank you for having me on your show. I really enjoyed it. I appreciate it.

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