And transformed scientific discoveries into life-saving medicines.

How David J. Bearss co-founded Halia Therapeutics

And transformed scientific discoveries into life-saving medicines.

The Founder Series is a column by and about Utah founders and how they got to where they are today. Click here to read past articles in the series.

Starting a company is interesting.

I’m a scientist by training and have often considered myself the world’s most reluctant entrepreneur. Halia Therapeutics is the sixth company I’ve started, but most of the time, I still think of myself as the guy who used to wear a white coat and work in a lab.

Halia Therapeutics has my full attention, though. My colleagues and I are in the middle of clinical trials and developing a drug that could be a game changer in the world of health care, but it’s even more than that: we have a shot at completely changing the world.

A starting point

The year I was born, my grandpa died of colon cancer. My mother also died of the same disease—earlier than she should have. My life was impacted by an illness that took the lives of those I would have liked to have grown up with. Our family risk is heightened, and we talk about that often. 

Being affected so early dictated my future path. Even as a kid, I told people I wanted to be a scientist and cure cancer. Kids say that kind of stuff, but I was serious. When I learned that developing new treatments for cancer was something I could study and do, I devoted my entire life to it, becoming a student and learning how to do scientific research.

Could I come up with ways to alleviate human suffering? Could I help lessen the kind of heartache that comes from family members dying of cancer?

In graduate school, I was fortunate to be on a team that discovered a gene that turned out to be very important in cancer. This gene, called histone deacetylase, is involved in the reprogramming of normal cells as they transition to cancer cells, allowing them to take on new properties and grow and spread through the body. My work as a graduate student caught the attention of a famous cancer researcher, Dr. Daniel Von Hoff, who offered me a postdoctoral fellowship and became my mentor. Dr. Von Hoff taught me all I needed to know about discovering and developing a drug and finding the right people to treat with new drugs.

Amazing doors opened, and I learned to have the courage to walk through them. I had a faculty position at the University of Arizona with funding for my research and a large laboratory of young scientists. We discovered several novel drug targets in cancer cells and were able to develop two new drugs to inhibit two of these targets. This left me with a choice. Either stay at the university or take the chance at starting a company that would develop and test these drugs. I knew nothing about starting a company, but betting on myself seemed the most logical idea. Nobody knew this stuff better than I did. Nobody appeared to care more.

Helping people meant being involved in moving scientific discoveries forward. It’s become my life’s theme, and it’s what I’ve spent my career doing. For the last 25 years, I’ve taken scientific discoveries and turned them into new therapies, and I plan on doing this for the next 25 years.

Halia is born

Halia Therapeutics is an example of trying to move the needle in the right direction. Over the years, I have taken drugs into clinical trials and tested those in people with different diseases. Without any kind of exaggeration, some of what I have worked on has literally saved lives. That’s humbling.

When we started Halia in 2017, it was because a geneticist and dear friend of mine, John “Keoni” Kauwe (a Halia co-founder and BYU-Hawaii’s current president), came to me with a scientific discovery.

He discovered a family in northern Utah that had a known genetic risk factor for developing Alzheimer’s, but when he looked closer, nobody seemed to have this disease. He further identified that this family had a second polymorphism in a gene that seemed to protect them. When he came to me and asked if that was interesting to me, if we could turn this work into a new therapy to protect others from possibly getting Alzheimer’s, I said yes, we should do it.

And transformed scientific discoveries into life-saving medicines.

Photo courtesy of Halia Therapeutics

Utah is one of the great places in the world for human genetics. Years ago, our state government and the University of Utah had enough foresight to merge The Church of Jesus Christ of Latter-day Saints’ genealogical database with public health records. That turned into a gift called the Utah Population Database. 

Basically, it allows us to ask questions in Utah that you can’t in other places. Searching this database, you can find families that have certain diseases and identify those who may be at risk due to genetic predispositions. It’s why Dr. Kauwe was interested in researching within Utah in the first place—because of the overwhelming support and access to resources here.

Halia Therapeutics began. It centered on the idea that we could turn a gene mutation that offered resilience against Alzheimer’s into a therapy that didn’t exist yet.

Discovery within a discovery

Along the way, we found that the polymorphism that provides resilience to Alzheimer’s blocks chronic inflammation in a unique way. At the time, the old idea that Alzheimer’s is solely driven by plaques forming in your brain so it doesn’t function properly was being replaced by the discovery that inflammation is a main driver of the disease. The dysregulation of the inflammatory process leads to neuronal degeneration. Many people accumulate plaques in their brains as they age, and yet very few people with plaques go on to develop dementia. What we now know is that everyone with plaques doesn’t have Alzheimer’s, but everyone with Alzheimer’s has inflammatory signaling happening in their brains.

That’s an important discovery: a connection between inflammation and neurodegenerative diseases. It’s why we started the company, but we’ve expanded our ambitions, as almost every disease has an inflammatory component to it. It is remarkable how much our own immune systems drive many of the diseases that afflict us, especially chronic diseases associated with aging. This was far bigger than what we originally thought it was. If we could stop chronic inflammation, it could potentially treat nearly every disease you can think of, from Alzheimer’s to cardiovascular disease to cancer to disorders with the skin, intestines or liver.

At Halia, we have discovered a way to turn off this chronic inflammatory pathway, meaning we can treat chronic inflammation. We’re in early clinical trials, testing this now. We don’t yet know whether it works in real human patients the way we think it does, but we’ve tested it and shown it can turn off inflammatory signals everywhere we’ve looked, from the brain to the skin to the lungs, liver and intestines.

Changing the world

Twenty years ago, we thought of inflammation as a double-edged sword. What we’ve started to appreciate more recently is the difference between acute and chronic inflammation and how each functions inside the body. When it’s chronic, it has no positive effect that we understand presently, while acute inflammation is part of the normal healthy response to damage and infection. If we can find a way to turn off chronic inflammation, you won’t have to take this drug for the rest of your life but perhaps intermittently, when inflammation flares up.

Maybe it will be used more like nonsteroidal anti-inflammatory drugs like ibuprofen and only when you’re experiencing pain or discomfort, for example. The question is, how might it be used to prevent diseases like cancer? The earliest stage of cancer includes inflammation. What if we could stop it at its earliest stage, preventing it from moving through the whole body?

If we can find a way to show we can turn off those pathways, then this drug has the potential to change the world. It’s funny to say that, but it’s true. Look back at the history of the world—penicillin changed it entirely. So did antibiotics. So did hormonal contraception.

New drugs can change the world. In the past 100 years, we have started living longer lives because we don’t die of infectious diseases. We developed drugs to move us forward in living longer. The focus today is not just on increasing lifespan but what we call ‘healthspan’: living longer and healthier. That excites me: the vision of what this could turn into. We could be sitting on therapies that prevent the major causes of mortality and morbidity, the reasons why people get sick and disabled. I dream about that, but it could happen. This discovery could be that big.

"Given my history, if I can make an impact in cancer research, I will. But I also look at the main killers out there, whether it’s heart disease or Alzheimer's. If I can make an impact in either of those areas, I’ll do so. At this point in my life, what motivates me is trying to keep more grandpas and moms around longer. That's what I care about."

And transformed scientific discoveries into life-saving medicines.

Photo courtesy of Halia Therapeutics

Make more mistakes

I’ve made every mistake you can in organizing a company correctly. Over the years, I’ve gotten better at it, so getting off the ground with Halia was easier. It’s never easy, but the lessons I’ve gained have allowed for a smoother experience.

I was so naive when I started my first company. I sold my house and car to keep people employed. We were on the verge of bankruptcy and incurring tremendous amounts of debt, but I was so committed to making it work I put it all on the line. When risk happens often enough, it stops scaring you so much. You learn to put your heart and soul into anything, especially when success is your end goal.

It may take some time to learn what those goals are, too. Every company I’ve been part of has started somewhere other than where they ended up. We were focused on Alzheimer’s in our early days and discovered a remedy that can potentially work almost everywhere. That created its own challenges. If it works for all diseases, where do we start? What do we try first?

We’ve been rigorous in deciding where to test this drug throughout its journey, from preclinical to testing in the lab to clinical testing. We’ve been as smart as we can. In science, you don’t know what you don’t know. You don’t know what the unknowns are. You could have 100 different places where this drug could work, and out of those, 90 of them would be positive, and 10 would be negative. I’m perfectly capable of choosing one of those, and I think I have in the past, so I am focused on trying to get this right.

Being careful with our decisions is integral to what diseases we want to explore and how quickly we can acquire data. It’s the driver for any scientific endeavor: what data can we generate? What decisions can be made based on that data?

So far, we’re headed down a good path. We have a growing network of collaborators and supporters and can access the right kinds of patients at the proper times. We can show that this drug does what we believe it does.

I can’t tell you how many people come to me with their ideas, saying, for example, “What about inflammatory bowel disease?” Yes, this drug could work there, too. But we can’t do everything. As a small company, we might only be able to tackle one or two areas total. All we can do is commit to the best decision possible based on the information we have at the time. 

Stay curious

A lot of folks would say it’s not a wise business decision to have a highly technical scientific person running a company—very few can actually run one well. But it’s important that we stay focused on research and science. If we lose that, we’ll get off track fast. So, we remind one another all the time to follow the science. It’s not true for every business but always will be for ours.

The tagline we developed for the company early on: “Good science is good medicine and good medicine is good business.” In our world, science is the beating heart of all we do. It is the business. From a business perspective, if we can make a good medicine, we can turn that into a good business. But the science needs to be absolutely right. It comes first.

Moving forward means heightening our awareness. For me, that means getting up to read at 4 a.m. every morning. I’m constantly trying to expand the way I think about what I do personally and what we do as a company. It’s how I’ve been able to look back on and push the envelope so often. I’ve started multiple companies and projects because of one major reason: I’m constantly trying to learn and add new approaches to all I’ve gained in knowledge already.

Part of that is being naturally very curious. That’s part of being a good scientist, asking, “Why is it this way? Does it have to be like this? Could it be different?” Being in constant search of those answers keeps me going.

Given my history, if I can make an impact in cancer research, I will. But I also look at the main killers out there, whether it’s heart disease or Alzheimer’s. If I can make an impact in either of those areas, I’ll do so. At this point in my life, what motivates me is trying to keep more grandpas and moms around longer. That’s what I care about.

People give me a hard time about this, but I literally dream about the possibilities of what can happen. I wake up and send emails that start out, “Hey, I just thought of this while I was sleeping.” Yes, while sleeping! That’s how engaged I am with all we are doing and all we will yet do.

Dr. David J. Bearss is an experienced entrepreneur and drug developer with over 20 years of experience in academic and industry settings. He is an expert in small-molecule drug development and the use of genetic model systems in drug discovery. He has deep experience in translational research focused on drug development and the use of genetic markers to predict drug sensitivity. Dave has discovered 16 compounds that have had Investigational New Drugs (INDs) accepted and moved forward in clinical development and has been a founder of six biotech companies. Prior to becoming Halia’s Chief Scientific Officer in January 2021 and CEO in March 2022, Dave was the CEO of Tolero Pharmaceuticals, which was acquired by Sumitomo Dainippon Pharma in 2017. He also served as Chief Scientific Officer at Montigen Pharmaceuticals prior to its acquisition by SuperGen Inc. He stayed on as Chief Scientific Officer at SuperGen to have oversight of early drug discovery and development. He was the founding co-director of the Center for Investigational Therapeutics at the Huntsman Cancer Institute, an associate professor in the department of oncological sciences at the University of Utah, and associate professor of physiology & developmental biology at Brigham Young University. Dave received a Ph.D. in cellular biology from the University of Texas Health Science Center at San Antonio.