#121: Michael Bruckman (Haima Therapeutics)

Michael Bruckman [00:00:00]:

Where the trauma center is 45 minutes or an hour away, and then it takes 30 minutes to an hour to get access to the patient and stabilize them. Those minutes are super critical. And so this is a product that the biggest clinical need is putting it onto an ambulance and having a hemostatic product to reduce bleeding and reduce blood loss on the way, because that's going to reduce the effect of shock. And that's going to save lives of tens of thousands, hundreds of thousands of people every year who just because we don't have a product that will stop bleeding after the injury occurs, before they arrive at the hospital. So that's a huge, huge windfall.

Jeffrey Stern [00:00:41]:

Let's discover what people are building in the greater Cleveland community. We are telling the stories of Northeast Ohio's entrepreneurs, builders, and those supporting them. Welcome to the Lay of the Land podcast, where we are exploring what people are building in Cleveland and throughout Northeast Ohio. I am your host, Jeffrey Stern, and today I have the real pleasure of speaking with Mike Bruckman, the CEO of Haima Therapeutics. With a PhD in organic chemistry and additional training in biomedical engineering and management. Mike joined the founding team at Haima as CEO in 2018 and has led their commercialization, having brought in over $13 million in government funding to support their program over the last five years. Haima was the sole team selected by DARPA to receive funding in pursuit of manufacturing a fully dried whole blood product. Haima, based here in Cleveland, is a biopharma company developing cell and platelet inspired therapies for the treatment of bleeding land a variety of other blood related ailments. Haima's initial focus is on the application of their plateletinspired therapies to mitigate active bleeding and bleeding risks after traumatic injury, surgery, thrombocytopenia, and other rare bleeding disorders. Haima's lead technology, called Syntoplate, is a novel, fully synthetic hemostatic agent that mitigates bleeding by acting at the site of injury and amplifying your body's natural clotting mechanisms. I learned a great deal from this conversation with Mike. We cover everything from his path from academia to entrepreneurship, to the basics of platelets and the basics of blood biology, to the vast implications that Haima's synthetic platelet technology can have on the whole field of blood related diseases. So please enjoy my conversation with Mike Bruckman after a brief message from our sponsor. Lay of the Land is brought to you by Air CFO, whose story we actually shared back on episode 23 of Lay of the Land with Air CFO's founder and CEO Justin McLaughlin. For many founders, dealing with finances and taxes is stressful, confusing, and time consuming. Yet, without paying proper attention to your finances and taxes, you won't be able to produce accurate nor timely financials and forecasts for your team or for your investors. And even worse, if you miss critical tax deadlines, you'll get hit with unnecessary penalties from the IRS. These kinds of financial and tax missteps can jeopardize your entire startup and your vision. Running a startup is hard enough. Work with Air CFO and you'll get best in class finance, accounting, HR, and tax support. Air CFO takes care of your back office so you can focus on growing from startup to scale up as a layoftheland listener. Visit Aircfo.com for more information and to set up a call and tell them layoftheland sent you. Again. That's aircfo.com. The link will be in the show. Notes with your background in biomedical engineering, land a PhD in chemistry, I imagine there's a myriad of fascinating biological areas you could have chosen to focus on. To start, I'd love to understand how your journey unfolded, to arrive at this interest in working on treatments for bleeding disorders and other blood related diseases. Can you kind of take us through your journey to become a biopharma entrepreneur and how your experience informed this passion?

Michael Bruckman [00:04:24]:

Yeah, what a good and open ended question to start out with? Right. So I went through this process recently of thinking back and as most PhDs like to do, as they transition throughout their career, the like to draw these lines, connecting dots with purpose, right? And so I'm Midwest, or born and raised in this general area. I grew up in Rochester, New York, of a middle class family where the values placed on hard work, doing the right thing, and just being a good, honest person, right. Doing something hard work worth doing. And then I went to undergrad in chemistry at University of Buffalo, land it was there that I got my first kind of exposure to basic research. I knew I wanted to be in science, but then it was like, oh, what can I do with it? I didn't know I was coming right out of high school, and I think in my third or fourth year, I took a biochemistry class from a professor who I had heard through the grapevine that he had started his own company. I remember thinking, that's really cool. I want to come up with some new idea in my brain and then turn that idea into a product, either through basic research on the academic side or through translational research on the startup side or in a larger business. But I didn't really know how to do that or what to do. So continued to get my chemistry degree in Buffalo, then went down to University of South Carolina, dove a little bit deeper. So getting my PhD in my mind at South Carolina was like learning how to dig a mile deep but an inch wide in a topic to become that expert of experts. But that's what I did there. I learned how to think. I learned how to design and plan and organize and think creatively, but with a strategy. So then I kind of took that experience and I came up to Cleveland and joined a research group in biomedical engineering at Case Western Reserve University, where I got a lot of training in engineering, so taking the deep dive and starting to think a little bit broader. So maybe 100ft wide and 100ft deep. But you can kind of start thinking more about like, you can take this platform and apply it to cardiovascular disease and cancer and stroke and what else are we going to do? We're going to change the size, the shapes, and it's all been in nanotechnology along the way. But while I was that case, because of kind of the great infrastructure and system and educational system they have in place, I was able to audit like, a handful of biomedical engineering classes and entrepreneurship classes where I'd audit, sit in and get to know the professor. But I'd sit in on those classes and get exposed to like, all right, here's how you actually take an idea, patent it, and then get it out into the world. But while you're doing that, you better make sure you're talking to clinicians land, talking to the government and talking and thinking about how it's going to get paid for and then thinking about how you're going to pay for this whole company and raise funds and do all this stuff and build a team. And so then I think about it as I went from a mile deep, an inch wide, to 100ft deep, 100ft wide. And then as I got into the entrepreneurship side, it was a mile wide and an inch deep, kind of all the layers of thinking with a little bit of business experience too. And I jumped into my first startup company, which was almost out of left field in its application, but it was an experience in being on the company side. So we're making saliva glucose sensors, but we were using nanotechnology to do it, to enhance the signal. And I joined as director of Research land development. And what I learned was that if I'm the boss, I have to have a vision for what the team is going to look like. I have to have a clear plan on getting things done. And I was only reporting to the CEO, but I was also interacting with the board, SAB potential partners. And so I got a lot of exposure and training while there land. Then there's some writing on the walls that this was going to be a tough business. The investors were a little quirky, and so I started to ask around about what other opportunities there are in the Cleveland area, which is not very many. But coincidentally, when I was transitioning out, krista and Honorban, the founders of Haima, had just received a good bit of money from the government. And at the same time, Krista had gotten a job opportunity elsewhere. And so they were looking for somebody to kind of come in and lead the ship and they were developing. What we're developing now is this synthetic platelet. So it's a nanotechnology to mitigate bleeding land. It acts like platelets, and it bridged the nanotechnology experience I had from grad school and from postdoc. But I had also been involved in the project. Focus for my postdoc was actually in cardiovascular disease. So it was the same cells driving similar functions, but instead of figuring out how to detect where clots are forming in your body where they shouldn't be, like in heart attacks and strokes, I was trying to get them to form at a specific site to stop bleeding. So the biology was almost the same, but it was the purpose and what we were doing that was slightly different. So we were able to kind of combine 20 years of experience into this one opportunity. Wow.

Jeffrey Stern [00:10:00]:

So it was really quite a serendipitous alignment there.

Michael Bruckman [00:10:03]:

Yeah. Which I think is pretty common in biotech and pharma. Kind of all works out.

Jeffrey Stern [00:10:09]:

Yeah. Well, I want to get into, obviously all the work you're doing at Hymea therapeutics. I think, though, both for my own edification and perhaps for the benefit of those listening in, if you could just give us kind of a baseline explanation, assuming rudimentary biological understanding of what the core concepts and definitions we might need to grasp here to fully appreciate the work that you're doing.

Michael Bruckman [00:10:37]:

Yeah, for sure. So our fancy tagline is we're making cell inspired therapeutics, and what that means is the target initial cell is the platelet. Platelets are the cells in your body that basically circulate with not much else to do unless they detect something wrong. And that something wrong usually comes in the form of a hole in your blood vessel. And once they detect that something wrong, they start working with each other to plug that hole and stop the flow of blood. And so if you think about it, it's kind of like stacking up a bunch of sandbags to stop the flood of water. And so the platelets are these big, heavy sandbags, and they are designed in a way to stick to each other and just form this nice sticky plug. They call it a clot that stops the bleeding. And then once the platelets do form that clot, then they work on generating their own version of cement that stabilizes everything, makes it so that once that scab is formed, for lack of a better word, it's not going to break open again. So what we're doing at Haima is we've taken this. What the platelets do is they stick to the bleeding site land, then they stick to each other, and we've mimicked those functions on a smaller, very fully synthetic nanoparticle. So a platelet is two microns in size. A nanoparticle is 0.2 microns in size, so it's ten times smaller, but it has the same sticking and aggregating functions. So it works with platelets, kind of like extra little sandbags to work with the big sandbags to plug the hole really quickly. And if you think of what we're putting on the surface is kind of like velcro. So we're putting little hooks onto the surface of these nanoparticles that are allowing it to kind of stick to the other platelets and the injury site, the bleeding site, to help all of these sandbags stick together and form that plug and stop the bleeding. Wow.

Jeffrey Stern [00:12:48]:

It's fascinating, that kind of picture of it. Where did this idea of synthetic platelet technology come from? And maybe with that, what are the problems with organically? The way we do this?

Michael Bruckman [00:13:01]:

Yeah, what people do now is they just get a bunch of donors and collect their platelets, their donor platelets, the biological product, store the until they're needed and then transfuse them. There's a lot of problems with that. You can only store platelets for a few days because you have to keep them on a rocker. So, like, put them on a boat at room temperature and rock them back and forth. That's the only way you can store them right now. And because of that, they're susceptible to basically going bad. It's like putting fresh fruit out on your counter and hoping that it's going to last a long time. Well, it's just not. So we have to throw them away after five days. And if you think about every platelet product that you collect, you have to get rid of every five days. That means you have to constantly be collecting platelets along with other blood products. And this creates a huge logistical problem. And so that's one of the big problems with platelet products, the natural products. There's other ones. Like they have an infection risk, because if you collect a unit of platelets from an HIV patient and that patient that screening doesn't work, you inevitably give the donor the donor a lifetime infection. And so that's something that can be avoided. If we're able to make a synthetic product like the one that we're developing at Haima platelets have all these problems. The value that a fully synthetic product brings to the table is that you can store it on a shelf, you can take it anywhere. It's super stable. It's going to be cost less than you need a unit of platelets, which is the real deal. And it works every time. It doesn't have any variability in how it functions. And so there's a lot of good value propositions that our product kind of brings to the table to meet or exceed the expectations of clinicians.

Jeffrey Stern [00:14:58]:

So going back to the founding and maybe original research behind this, what does the process look like for actually developing synthetic platelet technology? How does this come to be?

Michael Bruckman [00:15:13]:

Yeah, it's a good question. And so for anything in basic research that starts in the academic space, it's all about incremental advancements. Rarely is something such a leap land an advancement. That's why they have Nobel prizes for extraordinary leaps in research and development. This is a perfect example of an incremental advancement. And then another, and then another, and then another. Where the original research was conducted by the founder and inventor, dr. Anurban Sen Gupta at Case Western Reserve University when he just joined back in the early two thousand s two thousand and two, two thousand and three. And he was working on stents and medical devices that would be interacting with blood in your vasculature. So ECMO and tubes that blood would interact with, plastic that blood would interact with, and coming up with ways to prevent clots from forming, to do deep research into investigating what platelets or what's driving, like, thrombotic complications, so, like, strokes and heart attacks and patients that have sense what's driving that and how can we prevent it? Over time, he started recognizing there's actually a huge need after interacting with a number of clinicians, that there's really no good products to stop bleeding, especially in patients after traumatic injury and those getting surgery. Right. So he started thinking about all of his biological experience in Cases BME and thinking about, well, I know how platelets work to form a clot. Why don't I try to design a miniature nanoparticle or miniature platelet to mimic those functions? Land so he got his first funding for that idea back in 2000. Land Seven from the American Heart Association. And after he got his first funding, it still took about four years to get his first peer reviewed publication or first real demonstration that his idea was working. His original intentionally designed concept of mimicking multiple functions of platelets and putting it on a single particle could really provide a significant rescue effect for a bleeding scenario. And that's around the time when Krista got involved in Dr. Senegupta's research group. She got involved as an undergraduate in Cases BME, worked for a couple of years and then transitioned to doing her own PhD graduate work in his group and really took off and ran with the project. And they ended up publishing three or four key pivotal studies and peer reviewed publications and filed patents. And so if we think about the first funding was in Seven, the first publication is 2011. Their first patent was issued in 2015. And then after that, then we have a patent family or intellectual property protection over the products. That from the entrepreneurship side. She's like, I think we can start a company. There's clearly a medical need. We have a technology that can meet that need, and it's protected by some patents to provide value for the company. And so then she formed the company, along with Honorbound, in 2016, and then started working on writing federal grants to get funding because it was too early for angel or venture capital funding. Land so the main investor in these early types of ideas is the federal government, national Institute of Health, Department of Defense, State of Ohio. And so she went after a lot of those funding opportunities because she was at Case. Stern they were both really fortunate that Case has a number of programs internally to support these translational ideas. They have this William Coulter Foundation funding the have their own internal NIH funding, their own internal State of Ohio funding for entrepreneurship ideas, translational ideas, as well as this kind of foundation called the Council for Advancing Human Health or Coffund. And so they were able to take advantage of all of these internal opportunities to really build up the infrastructure of the company, identify what are the key milestones that we need to meet, who's going to fund this, what's the initial clinical strategy? How do we get to market? How long is that going to take? What key stakeholders do we need to be talking to? A lot of that initial strategy, initial framework for a company got put in place while she was at Case Western.

Jeffrey Stern [00:19:59]:

So building on that, you had mentioned in reflecting on your first startup experience that if you were to lead the organization, you need to have set the vision right and where you're trying to go. How have you thought about that in the context of Jaime when you came on board to lead the organization? What is that vision you set out to achieve?

Michael Bruckman [00:20:20]:

Yeah, good question because the vision for the company and the strategy for the company has both changed quite significantly and stayed the same at the same time. So when I first came on, the vision was to develop a single product, get funding for the Synthet program for this hemostatic agent, get it into market, and find a partner that would want to take it. The rest? Of the way or acquire us or provide some funding to build out the company into a large, functioning organization that has since grown land morphed into what I kind of started at earlier of this platelet inspired therapeutic company. And the reason being we want to transition from this single technology to like a platform technology company is that it provides a lot more value for not just for investors, but internally. We're all scientists at heart and we want to solve as many problems as we can with the tools that we have. So we have a tool, we have a knowledge base, we have a team in place that can leverage and we understand the unique biology of platelets and how they function, not just in stopping bleeding, but how they function in driving strokes and heart attacks and how they function in progressing arthritis and atherosclerosis and cardiovascular disease. But also there's been some new research interestingly over the past 1015 years on platelets role in cancer metastasis, in sepsis and infection, in driving these other chronic or very acute diseases that we can kind of leverage. What the platelets are doing and what the cells are doing in these diseases and use them as either targets to deliver cargo or we can start influencing by either amplifying or stopping what the cells are trying to do in those diseases. And the first program, synth plate is a perfect example where we're trying to amplify what platelets can do to stop bleeding so that they can stop bleeding more quickly. In other diseases, like arthritis or deep vein thrombosis, we want to prevent, as well as, like, heart attack and stroke. We want to kind of prevent what platelets are doing there because they're going a little haywire. They're like, hey, this looks like a bleeding site. We're going to start forming a clot or doing things that look like we're stopping bleeding, but actually it's making the disease even worse. And these are usually in elderly patients. And so there's no genetic support for these actions and these mechanisms to get weeded out through selection and so on.

Jeffrey Stern [00:23:03]:

So with the evolved vision and as it continues to evolve over time, just in the breadth of applications, this potentially has just to kind of level set. What does the company look like today? You mentioned syntho plate as kind of the initial product offering, if you will, how does the business actually work here?

Michael Bruckman [00:23:27]:

Yeah, so all the value of the business right now is in the syntho plate program. Right. So if I go out and I pitch the vision, I present the vision for the company is like, we as a small team are developing a technology. The development of that technology is going to derisk the development of other technologies. So by getting synthetic into the clinic, we can then say, like, all right, we know how to make it, test it and store it, and we can apply that knowledge to the next product. And the company is pretty small. So Krista and I are part of the leadership team. We have three part time members of our executive team. Land, our chief medical officer, Matthew Neal, who's based out of University of Pittsburgh. Dr. Sun Gupta out of case. Western is our chief technology officer. And then we recently recruited Tim Polora, who is our executive chair, who brings a lot of entrepreneurial experience. So he started seven, eight companies, led them as CEO, and raised $100 million and seen a few exits. But he's also brings the drug development experience. He's taken eight to twelve drugs from preclinical into the clinic. So he brings that knowledge of, like, all right, there's a pothole over there, there's a pothole over there. There's a hurdle there. We're going to have to jump over. Instead of trying to walk around, it's going to be easier. So he brings a lot of that experience to the team. So that's the basis. And then to get everybody involved and remain active without having basically hardly any funds in the bank, our currency right now is ownership of the company land, so we're able to recruit executive management based on equity. Our board of directors is all incentivized with equity. And then our scientific advisory board, who we meet with on a somewhat regular basis, is join the company for the potential right to be part of something that they see as a product that could help them in their practice because it's made up primarily of clinicians. And so you have to kind of mix this selling the vision of the company, selling the potential, using ownership of the company to get other really smart, really experienced people to weigh in and provide me with as much. Guidance as possible so I can go out and tell a story that makes sense, that is low risk, that I could never come up with a strategy on my own. That's why I build the team. That's why I take the advice and all that.

Jeffrey Stern [00:26:01]:

At the same time, there's been, I believe, over 13 million in government funding. DARPA has selected Haima in the funding of a dried blood product and currently raising a pretty considerable round as well. Is that right?

Michael Bruckman [00:26:21]:

That's right. Yeah. So the DARPA project is really exciting, and it's one of those things that only DARPA can do because it's very high risk but also very high reward. Right. Land you can clearly see the level of risk involved in the amount of money that is required to get us to a meaningful endpoint, which is demonstration of safety and efficacy that's comparable to whole blood, which has evolved to be a perfect treatment fluid. Right. That's why it keeps everybody alive. So we're trying to naively try to replicate, create a fully dried replicate of what evolution has created over the millions of years. That's a recognition in my mind of the amazing team that was put together to propose the development of this product. I'm quite aware there was a number of submissions of similar teams. Right. So each team had to have a platelet or a hemostatic component, a red blood cell or oxygenation component, and a plasma component. That's the primary components of whole blood. Land DARPA recognized that we had the best team, but this is something that could be really huge, not just for the company, but for the public in general. Right. The recognition on the Department of Defense, for all of our other funding is incredibly important for us because we're in a clinical space in stopping bleeding that is not as attractive for the big venture capital support. There is interest. Don't discount that. There's absolutely interest. But we're creating a drug that stops bleeding, but it's stopping the flow of fluid. Right. So there's inherent risks. We believe we have a product that is very low risk based on how it's designed. But historically, these products have not done so well, as evidenced by there's none in the market that we're replacing. We're creating a first to market drug. But clearly the NIH and the Department of Defense recognizes and BARDA we don't have any funding from yet they all recognize that it's a huge clinical need and it's a huge risk. And so that's how we're able to leverage our NIH and DoD partners to continue supporting us as we derisk our product development, our product. And the further we can derisk it with their funds, the more attractive it becomes to venture capital, which I was just explaining to somebody earlier today. Getting government funding for a drug development program, or even any kind of biotech development program is like driving on the highway. But you set your crews at 35 or 40, right? You're making progress, but you're not going real fast. When you're able to get to a point where you can remove the governor land speed, it up to 70 or 80. That's what happens when you're able to get that BC funding. We're going to start making progress real fast and derisk the get to where we need to go much, much more quickly. And so that's where we're at right now with trying to raise our Series A's to get to a really valuable milestone, a meaningful milestone, with what we consider a reasonable fundraise ask. Of course, that's why we wouldn't ask for that much. We're not over asking or under asking. Sometimes this is just the cost of doing business in our space. And so it's unique when you compare us to say, like a moderna, where, you know, they, they went from new product to clinical FDA approval in, in, you know, less than twelve months, whatever. I don't know the timeline was. But they were able to start with, you know, a billion or more dollars cash in the bank and a large team, and ten years of industry funded research from BARDA, from DARPA, from these big government agencies, to derisk it, all the technology, all that platform technology, to a point where, all right, here's a big, major clinical need. We can put it all on fast forward. They were going a million miles an hour on the highway, right? We just want to set it to just over the speed limit so that we don't get into any trouble along the way, but we're going as fast as we can.

Jeffrey Stern [00:30:51]:

So you introduced a lot of ideas there, but two that I want to expand on a little bit. One is this idea of competition in that you're almost creating a new market that doesn't really exist, but also that there are others competing in the space. So we can put a pin in that and I'll just introduce the other, which was about scale, right. It's one thing to prove that you can do this in theory and in research in the lab, and it's a whole other to derisk it and do it at scale. So in whichever order you'd like, we can kind of take these two topics, but I'd love to kind of hear your perspective on both of those.

Michael Bruckman [00:31:33]:

Yeah, so that's a big concern with making going from a clinical trial where you tested in 1000 people to, all right, now we get to make it available for 10 million people or a million. That's a multiple magnitude order of scale. Land infrastructure that's required. And that's an area that we feel really strongly that we have a strong advantage. And we can leverage the success of the modernas and the Pfizers and the biointex and the development of their lipid nanoparticle vaccines because we're using essentially plus or minus a few things to manufacture our product. So it's the same processes, some of the same types of starting materials, the same purification methods or similar purification methods. Land we've developed a method to freeze dry down to a powder so we can store it in a really small vial, just like the vaccine comes in, these little ten or 20 mil one inch tall biles. Ours will be a similar product. And because the dose that's required is anticipated to be relatively low, based on all of our early testing and the scalability has been demonstrated over and over again with all these different lipid nanoparticle type products, we believe we can make enough drug product to treat 100,000 people in a one week period in one site. So, I mean, we can do that 50 weeks a year, 52 weeks a year. Land you can do the math. That's enough. And that's out of one site. There's not that many people that bleed in the US every year that need treatment. When we start thinking globally, that's when maybe we need to open a second or third manufacturing site. But the footprint isn't that big for manufacturing these types of products. And there's a number of manufacturing organizations that have the capabilities. And someday if we get to that stage, we'll be speaking with the state of Ohio to see if they want to support our building out of their own manufacturing facility.

Jeffrey Stern [00:33:43]:

So I think you're hinting at the future. Land what the goals could be. How do you think about success and what what that impact you'd like to have?

Michael Bruckman [00:33:54]:

Looks like, yeah, so the vision for the company has to be always to build a functioning company, right. We can never while part of our strategy is to form a strategic partnership with a large pharma, a large biotech company with similar products that they're already marketing in their pipeline out there selling to doctors and hospitals, we have to plan on building a self sustained company. What that means is that the longer we are an independent company, which we are now, of course, the further along we're going to get and the more incentive we have to build out our own manufacturing capabilities. And if we're able to get to that stage, say in the next four or five years during early clinical trial testing, then, yeah, we're certainly going to continue to seek strategic partnership. And ideally, we would maintain all of our manufacturing infrastructure and then partner with a large pharma, a large biotech, and they would manage regulatory and sales and distribution. Land getting allowances for global sales, global distribution. There's a lot of when we go to that scale of business, we would have to go from 25 to 50 people to 500 to 1000. And that's a scaling problem that's already easily solved by established companies. But if we don't get that partnership, we still have to build a company with a vision that we're going to succeed. So seek partnership, have the conversations, but if in the background, continue to build value by building out the infrastructure, building up the expertise, so that even if we are acquired, it's more of a they're going to buy our building land, just slap their name on it. But keep all of the people in place. And keep all the infrastructure in place.

Jeffrey Stern [00:35:49]:

You've mentioned, I think, a few of these already, but I think just practically it would be helpful to understand some more of the use cases of how this comes into play for someone who is experiencing one of these problems.

Michael Bruckman [00:36:05]:

Yeah, the biggest clinical need is by putting this thing on ambulances and letting first responders say like it was a car accident, their blood pressure is low, they're probably losing blood somewhere. Let me establish an IV and get this thing in them. Now while we worry about stabilizing the patient and transporting them back to a trauma center you can visualize in Cleveland, that's a problem, but it's not a huge problem. But if you start driving to other areas of the country or even other areas of Ohio where the trauma center is 45 minutes or an hour away and then it takes 30 minutes to an hour to get access to the patient and stabilize them, those minutes are super critical. And so this is a product that the biggest clinical need is putting it onto an ambulance. Land having a hemostatic product to reduce bleeding and reduce blood loss on the way because that's going to reduce the effect of shock. And that's going to save lives of tens of thousands, hundreds of thousands of people every year who just because we don't have a product that will stop bleeding after the injury occurs, before they arrive at the hospital. So that's a huge, huge windfall. There's a ton of other areas where it's going to be used. There's millions of surgeries every year. A lot of a surgery is essentially surgeon taking a knife and cutting people open. It can be really small, so maybe the blood loss is really tiny. But some surgeries orthopedic surgeries, hip replacements, knee replacements, spinal surgeries, basically controlled traumatic injury, they're getting patients to sign up and they're going to say, all right, come in. We're going to break some bones and remove some stuff and do some cutting. And that bleeding leads to all, if it's excessive, leads to all kinds of downstream complications. And so if we can reduce that blood loss, enable a surgeon to do their job more quickly because they're not clearing the field, that should improve patient outcomes quite significantly. And the third big area is in cancer patients and so the main treatments for cancers, bone marrow transplant, radiation therapy and chemotherapy, these all cause your platelets to just go away for some reason. We know the reasons. And so these patients require probably about a third to half of the donor platelet supply just to make sure that they don't bleed out. And the bleeding isn't always obvious in cancer patients. It's internal bleeding. It's GI bleeding where the have blood in their stool or nosebleeds that never stop, or they fall and bump their head and it just never stops bleeding. Right. So they're sometimes or they have a bruise, they bump their elbow, and then their elbow starts swelling up because they bumped a blood vessel and it didn't seal the wound right away. So these patients use quite a bit of platelets land. That's an area where we believe this product will help alleviate some of those stresses on the blood donation system.

Jeffrey Stern [00:39:11]:

Yeah, those are incredible. It seems like a lot of the potential applications fall on some kind of spectrum of depending on where you can get in the development and proof of efficacy of it that will allow you to treat different components. And I don't know if you can do this, but taking a step outside of Haima, how optimistic are you, for example, about developing a fully dried whole blood product and on the spectrum of synthetic blood as a concept? Right, yeah.

Michael Bruckman [00:39:43]:

No, like I said, it's a high risk, high reward path. If I take a look at just Heima and our product, there's an inherent risk. Right. We're not some special snowflake that is immune to clinical, regulatory, and manufacturing risks, and there are certainly unknowns that we don't know about. Right. So we bring in our own level of risk. Then you multiply that by the level of risk of our partnering companies who are making red blood cell surrogates for oxygen transport and freeze drying those and stabilizing them, and they're going to have their own set of risks. They have an amazing product, but that does not make them immune from their own set of manufacturing land, safety and efficacy risks and then getting everything to work with. Right now, we're partnering with a company making a freeze dried plasma, which is an incredibly complex mixture of salts and proteins that help your body to stay healthy after an injury. But mixing everything together in a consistent way to provide the value that's needed and test that in the clinic presents a certain level of risk as well. I'm optimistic about it because I can see that we've put together a great team and we have a lot of government support, and our counterparts also have significant venture capital support. So we're able to remove the governor a little bit and move at a faster clip than we had been able to previously. And that's going to enable us to leverage the team and experience that we have to answer any problems that come up when they do. And that's the value of the team. Right. The unknown. Unknowns are quickly answered by people with experience because they're like, oh, this is a little bit like what I had seen before, or technically I'd seen this, or I'm a pathophysiologist, so that's what these signals mean. So if we need to make changes, this is the change we need to make, or this is a safety concern, but it's not that big of a safety concern in the context of what we're trying to treat. So we have a great team, we have a few great products, and then it's just a matter of executing. It's going to be a long road for sure. I think we're probably a decade from getting a clinically approved, fully dried blood product, but we're getting onto the highway or not highway now, and we got enough gas to get us pretty far.

Jeffrey Stern [00:42:13]:

That's very cool. When you think about the road ahead of you, what has you most excited over the next year, over the next five years as you make your way towards that ultimate destination?

Michael Bruckman [00:42:28]:

Yeah, I'm really excited about getting our chance at Bat with our Scintill plate program, and by that I mean getting over the hurdle and getting it into the clinic. It frightens the crap out of me, but I'm also really excited to confirm that it's as safe as what we're seeing in our preclinical models and eventually seeing if it works the way we think it's going to work. Right, so we should be in the clinic in a year, land a half, as long as we're able to raise the funds, remove the governor, and get there quickly. And the idea that we're going to be putting a product technology into patients is really exciting. Being able to do so in the Cleveland area would be a cherry on top with VC funding for this small, scrappy, but very ambitious team led by Krista and myself. And I think our executive management team is very excited to do something meaningful in this space and follow through on the promises that we've made, especially to DoD and potential investors. So that's going to be a big one. Broadly speaking, I'm hoping that over the next one to five years, the Cleveland Pharma Biotech Devices diagnostics ecosystem begins to flourish. Right, I know Case Western is starting to make some moves. Ohio Life Sciences is getting more involved. Team Neo is getting involved. Cleveland Clinic is doing some things. The VA is going to start getting involved. So I think that there's a lot of opportunity to build the infrastructure, bring in top qualified, top level talent, and create a community of success where we'll be one of those pieces, I hope. And that's, I think, something that's been kind of missing from the area for quite a while now.

Jeffrey Stern [00:44:23]:

Hopefully we can piece it together here.

Michael Bruckman [00:44:26]:

Yeah.

Jeffrey Stern [00:44:27]:

I'm curious, as you reflect on the entrepreneurial journey so far, are there things that you have learned the second time around with Haima that you didn't with the first go?

Michael Bruckman [00:44:41]:

So many things. Yeah, so many things. The big one is team with experience in this space, getting people who have walked the walk in the past and getting them to give us advice. And there's a difference between people who have gotten their elbows dirty and done the hard work and put in blood, sweat and tears versus people who've been advisors to those that have done the hard work. Right. There's a difference between making a podcast and talking about making podcasts. Right. It's a lot of hard work that goes into it. All the homework and the energy right. And the thoughts that drives it. The value of having a network of peers that has gone through similar experiences or is about to go through similar experiences is something that over time, I've seen enough value in having it that I've joined a biotech CEO group out in Boston to get that experience right. So joining those types of groups earlier in the development of the program would have probably sped things up a little bit. There's always going to be technical hurdles, but I think the biggest education is making sure that we have a good team in place and it's the right team. And sometimes you don't know it's the right team until after you see how people do in their role. Right. And then you have to start thinking about maybe we need to make changes. Land being intentional about it, but people, people people sort of tell about it.

Jeffrey Stern [00:46:11]:

Always comes back to people.

Michael Bruckman [00:46:13]:

Yeah.

Jeffrey Stern [00:46:15]:

What do you feel are the particular challenges or complications that come? Entrepreneurship is hard generally, but my sense is that when you layer on the bio pharmaceutical component to it, that it's a whole level more complicated. What advice would you have for other folks building in this space in particular as they're looking to develop innovative therapies?

Michael Bruckman [00:46:43]:

Reach out to advisors and find mentors, find people that have done it before and just straight up ask for them to mentor. You ask for them to meet once a month. A lot of people are open to doing that, and if they're not, then they're not probably not a good mentor. Right? They're not interested in being a good mentor. So I've signed up for the Mass Challenge program several years ago and by effect, I ended up being a mentor afterwards to several companies that go through that program, startup companies, all in the life science space. And I still remain in touch with a few of them and meet pretty regularly. And it's not all about me giving them advice. It's about what am I going through? I tell my stories, what are they going through? They tell their stories and then we reflect on things. Land sometimes we walk away not giving advice, but really just feeling like, all right, you're going through a hard time. I'm going through a hard time. Let's go through a hard time together.

Jeffrey Stern [00:47:44]:

Yes.

Michael Bruckman [00:47:45]:

But yeah, the key is, I think, finding good mentorship early pays dividends. And that can be through university setting, through incubator setting through just reaching out to Google or LinkedIn, who leaders are at different companies that you admire or you want to be them someday and ask if you can talk to them once a month.

Jeffrey Stern [00:48:08]:

Pulling on the academic university thread for a SEC, and maybe this is a little detour, but how does the technology transfer process work? Land what could be done to unlock more of the latent value that's within the research organizations to get more entrepreneurship out of them?

Michael Bruckman [00:48:30]:

It's an area that I'm peripherally plugged into. So my experience with tech transfer is with the university system, I'll put it that way. We're fortunately located physically across the street from Case Western. And so that allows us to go and use their core facilities, right? And so that is really important time and money saving resource, because that means we don't have to buy or build any of the infrastructure on our own. We don't have to buy the expensive equipment, we don't have to build our own animal testing research center. We don't have to hire a bunch of people to do these things. And we don't need all that space. We can live in a small space, but access the resources across the street. Our other interactions are with tech transfer. Right? So Case Western owns our patents, so we had to negotiate a license to those patents. We're fortunate in that Case Western also has a seed investment fund, and they invested in the company recently. And so that provides us a small amount of capital to start speeding up a little bit and derisk the program more quickly. Now, inside, going from the inside out, I think they have good programs in place, and I know they hired a number of people to kind of support what the sport, the studies, or provide guidance on the studies that should be performed with that funding internally. The questions I have is where are the startup companies going or where is the IP going? So all life science technology is just patents, right? Small number of people or a big pharma company will come to university, look at the patents, look at the technology, see the patents. Land basically lay to use the patents pay to develop this technology. I know Case is an engine for technologies, for science. They're very successful at getting research funding, publishing on the research funding, and patenting their technologies. They're also good at licensing out their technologies. The question is, where are the licensed patents going? I live in the Bio Enterprise building, which is an incubator for life science companies. The tenants of Bio Enterprise have not changed very much in the past few years. There's a couple of other incubators in the Cleveland area. Maybe they've gotten some new tenants. Maybe not. I'm not privy to that information. And I think that's something that Case is trying to change and Ohio Life Sciences is trying to change. Land team Neo in that they're trying to create a better infrastructure for young scientists, young entrepreneurs, to take a technology that has promise and build a business around it with young, ambitious people. And then once you start getting successes that way, then you get successful entrepreneurs, successful people to stick around and do the next project to advise new entrepreneurs that come through the program on little things they could be doing differently. Or like, providing resources, or how to manage IP, or how to manage contracts, or how to go about fundraising, how to develop a clinical strategy, that kind of thing. What things to think about when building out your board and your scientific advisory board. That kind of advice comes from having a certain threshold of people in one spot that are able to interact regularly. The people have to be getting their elbows dirty. There's a place for advisors and consultants, absolutely. But when you're actually getting your elbows dirty and then you're experiencing real problems that need solutions very quickly. Land that's where having a close physical community adds a ton of value. Because if I can have a problem that is a clinical strategy question or a legal question, and I trust the CEO two doors down enough that I can walk down and knock on their door and be like, hey, do you got 15 minutes? I want to just bounce a couple of questions off you. Or create an infrastructure where once a month the leadership for Life science companies goes out and gets a meal together. Right. Maybe that's just personally funded, or maybe it's supported by Bio Enterprise or by Case Western, whoever it may be. Right. It's kind of about like, providing the opportunities for the less experienced entrepreneurs to get advice from the more experienced entrepreneurs. And that's something that I think that Case, as a private university in the area, should be able to find a way to work with Cleveland Clinic. They have a very strong innovations department, should be able to work with the VA, who is also very involved in basic research, but basic research towards DoD relevant topics as well as other area universities. I think University of Akron is doing great science, and Kent and Cleveland State, northeast Ohio is too small to think that Cleveland, in Case, is the center of everything. We need to be as inclusive as possible. Land consolidate resources as much as we can because I think that's going to provide the most value as the community grows.

Jeffrey Stern [00:53:59]:

Right, yeah. That density piece to the puzzle is really important.

Michael Bruckman [00:54:04]:

Super important. Yeah. I mean, if you're not bumping into people, they're not seeing your face, they're not asking questions, and you're not, like, getting things off your chest. And that's where you start getting new ideas on ways to think about how to manage a team, how to build a team. Trouble with safety or trouble with let's say you want to change how your lab looks and take wall down or put a wall up or order a bench or install a clean room. There's logistical things that just pop up, and you're either going to do a Google search or you're going to tap into your network. But the easiest thing is to just walk down the hall and talk to your friends. But you need a critical mass to.

Jeffrey Stern [00:54:45]:

Do that from people who have already figured out how to deal with that specific problem 100%. That all resonates a lot. Well, we've covered a lot of ground here. We'll close it out then with our traditional closing question, which is tied to Cleveland land is not for your favorite thing in Cleveland, but for something that other people may not know about, a hidden gem in the area.

Michael Bruckman [00:55:15]:

Yeah, I thought about that a little bit, and I was a little hesitant to say, my go to is the Rocky River Metro Parks area. Like, drop down right around the river, there's a super long, very beautiful metro park area with so much space and infrastructure for just enjoying the outdoors. As you get closer to the mouth of the river, going into Lake Erie, there's the marina, the Rocky River Marina right there, which has a little park. But then on the other side of the river from that marina is basically a hiking trail that goes along the edge of the river that nobody goes on. And so we can go there with our dog and kids land. They can climb up the hill and slide down, and we can let the dog off leash, and she can run all over the place because it's a half mile in, half mile out that's almost never used. So it's kind of like our unique, special place where we can go, we can have the privacy that we always want, and the kids can throw sticks and throw stones and play in the river. Dog can be off leash, and we can look across the river at the Standard Park with hundreds of visitors and there's fishermen in the river, and it's a really cool spot.

Jeffrey Stern [00:56:30]:

Well, hopefully we don't inundate the spot with the deluge of people now, but.

Michael Bruckman [00:56:37]:

You got to look for it. It's tough to find, so I'm not too worried.

Jeffrey Stern [00:56:42]:

Yeah. Well, that's awesome. Rock river. It's a beautiful place.

Michael Bruckman [00:56:46]:

It is, yeah, for sure.

Jeffrey Stern [00:56:48]:

Well, Mike, thank you so much for coming on and for sharing more about the work you're doing and your own story. It's really exciting. Very much looking forward to following along on your journey as it unfolds here.

Michael Bruckman [00:57:01]:

Well, thanks a lot, Jeffrey. I appreciate it. Yeah.

Jeffrey Stern [00:57:04]:

If people had anything that they wanted to follow up with you about, what would be the best way for them to do.

Michael Bruckman [00:57:10]:

So, yeah, just have them shoot me an email. They can use my work email. It's Mbruckman@haimatherapeutics.com and we're in the Bio Enterprise Building, located right across the street from Case Stern, so they're both pretty easy to find.

Jeffrey Stern [00:57:23]:

Great. Well, thank you again, Mike. Really appreciate it.

Michael Bruckman [00:57:27]:

All right, take care.

Jeffrey Stern [00:57:29]:

That's all for this week. Thank you for listening. We'd love to hear your thoughts on today's show, so if you have any feedback, please send over an email to Jeffrey at layoftheland FM or find us on Twitter at pod layoftheland or at sternJEFE. If you or someone you know would make a good guest for our show, please reach out as well and let us know. And if you enjoy the podcast, please subscribe and leave a review on itunes or on your preferred podcast player. Your support goes a long way to help us spread the word and continue to bring the Cleveland founders and builders we love having on the show. We'll be back here next week at the same time to map more of the land.