Banking on KC – Tammie Wahaus of ELIAS Animal Health
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Kelly Scanlon:
Welcome to Banking on KC. I'm your host, Kelly Scanlon. Thank you for joining us. With us on this episode is Tammie Wahaus, the founder and CEO of ELIAS Animal Health, an animal cancer therapeutics company. Welcome, Tammie.
Tammie Wahaus:
Hi. It's great to be here. Thank you, kelly.
Kelly Scanlon:
You have quite a story. Before we go in depth on all of your work, give us a brief overview of what ELIAS Animal Health does.
Tammie Wahaus:
Sure. So our mission is to improve veterinary cancer patient outcomes by bringing innovative novel therapeutics to the market. It's largely been an unmet need with very few products coming to market in the past 30 years. So we're really focused on improving the options that are available to pet owners when faced with that devastating diagnosis.
Kelly Scanlon:
This is primarily dogs?
Tammie Wahaus:
So we have been focused on dogs from a clinical trial standpoint and regulatory approval, but the technology has applicability to other species as well, for companion animal that's defined as dogs, cats, and horses.
Kelly Scanlon:
So what inspired you to start ELIAS Animal Health? You were working in the financial services industry at Ernst & Young. Why bioscience now? Animal Health?
Tammie Wahaus:
During my career at Ernst & Young, I worked in a whole variety of industries, including a little bit of exposure to the life sciences industry, and I really find learning and interacting with new industries fascinating. When I left Ernst & Young and I intended to retire, I decided I would continue to stay involved and do consulting and was doing some consulting for Ernst & Young clients in what they at that time called the Entrepreneurial Services Group. So these were small startup companies. Some were pre-revenue, some were already revenue, and they didn't have a need for a full-time CFO, but they had complex accounting issues. So started doing that consulting and one of the companies that I was involved with was a human health company that had this technology that was working toward a large fundraising capital raising activity so that they could launch their registering clinical trial in humans.
Through that process, I was consulting with them on complex accounting issues, but not really the life sciences issues. And then one of their key personnel had a devastating diagnosis that took him out of play for an extended period of time, and so they asked me to step in. So I stepped in and got more involved in the business. I actually became an employee of the company as I got more exposed to the technology. There's probably no one that you meet that hasn't had a close relative, whether it be mom, dad, brother, sister, child, or your companion animal diagnosed with cancer. As I learned about this technology, it has an excellent safety profile compared to my close family member who had gone through the chemotherapy route and radiation and you know how sick those patients are.
So I became fascinated with the technology and the opportunity to do something better for cancer patients. At this time, I was thinking human and we were looking at ways, we knew this technology had the potential to work across multiple cancer types, which is also a strategic advantage because I don't have to go create a new molecule or a new drug. I just have to figure out how it can be integrated into a treatment regimen in a new cancer type.
Kelly Scanlon:
You make it sound easy.
Tammie Wahaus:
That's not true.
Kelly Scanlon:
You just had to-
Tammie Wahaus:
Yeah, so the human company was working in brain cancer and how do we demonstrate that the technology is applicable to other cancer types? And so we started looking into can we do other types of cancers in dogs? And the more we looked into it, I went to one of the local conferences with the sole purpose of meeting Wayne Carter, who at the time was the president of the BioNexus KC. And I thought, if anyone can tell me who to connect with, it's got to be this guy.
Kelly Scanlon:
Yeah. And what time period is this?
Tammie Wahaus:
Oh gosh, that was 2012.,
Kelly Scanlon:
Which doesn't seem like that long ago, but in terms of cancer research, it's a long time ago.
Tammie Wahaus:
Yeah. So I did, and he connected me to Dr. Carolyn Henry, who was head of the oncology program at the time, at the University of Missouri. And through that connection, I asked a naive question, do dogs get cancer? And she said, "Oh my gosh, at a rate that is significantly higher than in humans."
Kelly Scanlon:
Really? I didn't know that part. Oh, wow.
Tammie Wahaus:
Yes. So then we really got into the dialogue with her and her team, Dr. Jeff Bryan, who became collaborators of ours over the ensuing 12 years to really try to understand could this be a product for the veterinary market or is this just a place to test? And we really became convinced that there was an opportunity for it to become a product. So not only could we help humans, but we could also help the companion animals at the same time. So as we began to put the pieces together, we then of course had to go ask the regulator, the USDA, can we do this in dogs? And so we got that answer and said, okay, then we need to launch a company because while it's the same technology, there's so many differences. It's a different regulator, a different patient category, a different customer base. And so we launched the company and we raised the capital in 2014.
Kelly Scanlon:
So when you say we, you're always recognized as the founder of the company, so did you do that with some other people? Sorry. So how did that work?
Tammie Wahaus:
One of the lead investors and the human health company, I was working closely with him to look at some potential merger transactions for the human health company. And so he and I spent two days in due diligence at the company. We got back to the airport and he said, "What do you think?" So, he could tell that I wasn't thrilled with what we found, and he just jumped right in and said, "Yeah, this is not a deal we want to do." So I said, "Okay, well how about this deal?" And I pulled the business plan out of my briefcase, handed it to him, he rearranged seats on the flight, so we flew home sitting next to each other, reviewed the plan, discussed it, and he agreed to become our initial investor in the animal health company in the launch.
Kelly Scanlon:
So you were the brains behind it, so to speak. You put the business plan together and he was the investor.
Tammie Wahaus:
And the founder of the human health company was also very involved and took the role of chief scientific officer for the animal health company so that he could help guide how we were moving forward with the technology and get the manufacturing set up. And-
Kelly Scanlon:
I think a fascinating part of your story is you were in finance, and I know that you learn a lot when you're working with them on their, like you said, complex financials and so forth. You learn a lot. But still, I mean, even if you had the scientific training, this would be such a difficult jump, I would think, but you surrounded yourself, I guess.
Tammie Wahaus:
I did. The chief scientific officer, Dr. Wood had been an instructor professor earlier in his career. So he was a great teacher, very patient. He had to tell it to me more than once. And I always say, I can't do what they do, but I can understand what they do. And-
Kelly Scanlon:
Which helped shape your vision then.
Tammie Wahaus:
Yes, and that's really important. And what I gained from, if anyone's out there thinking, should I go into business? I would actually encourage you to seriously consider going the certified public accountant route because not only do you learn how to analyze financial statements, but one of the big things you learn is how do companies' business processes work? What risks are they facing every single day? Because that's a question we ask when we decide we're going to, we go into audit a company, what are the risks that this company is facing and what have they put in place to mitigate that risk? And who's their regulator and what rules do they have to comply with? So throughout my whole career in public accounting, it was constantly learning, new company, new industry, new regulator, what are the rules and how do people respond to that? And then assessing is that adequate?
Kelly Scanlon:
Okay, so you get the company started and you have ELIAS Cancer Immunotherapy, which is the technology that you've been talking about. It's a product, and as you said, it's a significant innovation in treating canine cancer. So you had to go through a series of developmental steps, and I believe it was just January this year that you finally got the USDA's recognition of its efficacy. Tell us about that journey.
Tammie Wahaus:
Yeah, it has been a long journey, a little bit longer than what you would normally expect. And the reason for that is when you're dealing with these novel new technologies, the regulations that are in place don't necessarily directly lend themselves to how the regulator can manage. So from a development perspective, I said just a few minutes ago that we first just had to ask permission, can we do this? And so we got that letter and provided them the information that they requested, and then we said, then what is the clinical trial pathway that we need to follow? Because the most important thing you need to know about a therapeutic is how safe is it and how effective is it in the patients that are being treated? So we followed the traditional, is it safe in dogs? How does the mechanism of action work once it's in the body, what is it actually doing? Is it doing what we think it's doing?
So you cleared that hurdle on mechanism of action, which is required by the USDA, and then you go into a larger clinical trial in patients that have specifically the disease that you are hoping to get approval for. So in our case, that was osteosarcoma and we ran first a 14 dog preliminary trial, mostly to build on the safety data to make sure, but also that tells you some preliminary efficacy and the data there exceeded our expectations. And so we said, okay, now we can take the next step, which is run the larger randomized pivotal trial against current treatment options.
Kelly Scanlon:
So you start the second larger trial.
Tammie Wahaus:
To run a trial where you're enrolling a hundred patients and you're trying to do that in less than a year, we had to go out and we originally intended to open up five clinical trial sites and let them all enroll 20-ish patients, and we were all ready to go. We were preparing to launch the clinical trial in the beginning of April of 2020, which was two weeks after the pandemic closed the State of Kansas and so many other states across the U.S. So we didn't launch. We had to take a minute to try to figure out what are we going to do? Can you run a large pivotal trial during a pandemic?
Kelly Scanlon:
In five different locations, too.
Tammie Wahaus:
And in five different locations? As we were talking to the veterinary hospitals, they're like, well, okay, we can't even see patients right now. Because they all had to go figure out what are their protocols for allowing people in to see the dogs. And it took about four to five weeks for that to settle down so the hospitals could say, okay, we're ready. Normally when you open a clinical trial, you have all the clinical trial sites, you have this big launch meeting, everybody gets educated and boom trials open. And some people were telling me, you just need to wait until the pandemic is over. And I said, I have the investor dollars right now to run this trial, and I can't sit here and fritter away those dollars while I wait for a pandemic because it looks like it's not going to be over in two weeks.
Kelly Scanlon:
Exactly. Yeah.
Tammie Wahaus:
So we opened 2 sites in May, 3rd site in July, and I'm sitting there one quarter into the timeframe that I wanted these dogs enrolled, and I've only got three trial sites open. So we went back and said, okay, if we're going to meet the timeline, we've got to open more trial sites. So we bumped it up to 10 sites. Once we got a site open, they had their protocols all set so they knew what to do, if they had a COVID exposure, they knew what they were going to do to try to keep dogs on treatment and on schedule. So we got all hundred dogs enrolled actually in more like 10 months, we wanted it to be a year-
Kelly Scanlon:
But you've got very aggressive about it. So you have these dogs enrolled and you got through the clinical trials, and then in January, like I said, of 2024, you got your approval?
Tammie Wahaus:
Yes.
Kelly Scanlon:
You got the results that you were looking for?
Tammie Wahaus:
Yes, we got the clinical trial results, and it always takes longer than you anticipate, but it always takes longer to analyze the data, validate, verify, audit, all those things and get all the statistical analysis done, the safety analysis done and back and forth with a regulator answering their questions. And so we were very pleased finally in January to get the letter saying that your pivotal study has met the requirements for licensure. Now you move to the next phase. Then they want to be able to inspect your facility and ensure that you are doing what you say you're doing, work with you on what are you going to tell the docs? What are you going to tell the pet owners? All of those things have taken us well, we're not quite finished.
Kelly Scanlon:
Before it can become commercially available-
Tammie Wahaus:
Yes, and we actually are commercially available today under an experimental label, which is pretty uncommon. And it has to do with the fact that when we got into the market, ours is an autologous therapy, and so we make a single batch for each patient. So it's personalized medicine, and there was a significant unmet medical need out there. And so we met these fairly refined and strict limited circumstances to where the product could be made available for sale with an experimental label on it that says it hasn't been tested, it hasn't been approved, but a veterinarian can choose to use it.
Kelly Scanlon:
So in the roll-up to making it commercially available without the experimental label, you are expanding your manufacturing area, correct?
Tammie Wahaus:
We are, yes. We were in a venture accelerator for the first almost 10 years, and in early 2024, we moved from the accelerator into our own leased facility. That takes time. Now we want to manufacture here. And you go through what they call a technology transfer program so that they're confident your new facility can produce the same thing your old facility did.
Kelly Scanlon:
Let's step back for a minute. You mentioned that you're working in particular on osteosarcoma in dogs. What kind of a cancer is that and what does your particular treatment at a high level, how does it treat that?
Tammie Wahaus:
Osteosarcoma is essentially a bone cancer, so it can arise in any bone, but it is predominantly seen in the long bones. So like in humans, it's in legs typically, and in the dogs it'll be in one of the forelimbs, it may also appear in shoulders, or there can be a rare number of cases where it's on somewhere else on the body. But where we see it most is on the forelimbs. What our therapy does, it's personalized medicine for each patient. And the reason we believe in that is that every cancer is unique. Even though we call this osteosarcoma, two osteosarcomas are not the same. And the reason for that is that type of cancer is a mutation of normal cells, and by definition, mutation means I'm mutating differently and so that no two are alike. So what we do is the patient will undergo surgery to remove the primary tumor.
Unfortunately with osteosarcoma, 90% of patients will have micrometastatic disease, so you can't see it, but it's there. And where it's going is to the lungs. So those dogs will die of pulmonary metastasis in the lungs. So what we do is we take that primary tumor and we manufacture a vaccine that is used to inform your immune system what that cancer mutated cell looks like. So once we do that, the immune system is capable of reading that information that it gets in the vaccine, transmitting that information to all the parts of the immune system that needs to know, training the immune system to recognize the cancer cells. But we don't stop there. Because we know cancer is moving fast, is very adept at evading the immune system, cloaking itself so that the immune system when it comes by and says, oh, okay, so yeah, you're okay.
So what we do then once the immune system is informed by the vaccine, we collect those informed immune cells, manufacture them into a large number of what we call killer T-cells, and the patient gets an infusion of the killer T-cells. What the killer T-cells are doing is they know what they're looking for, they're mad about it and they're going into the bloodstream, which enables them to very quickly get throughout the body looking for the cancer cells.
Kelly Scanlon:
So that brings up two thoughts. One is how long does it take for the process you just described to actually in real time in a dog? And second part is do they have the same side effects that a human would have going through chemo or going through a treatment for cancer?
Tammie Wahaus:
In terms of timeline, that is one of the strategic advantages we think we have with our technology. When you compare what we are doing in the dogs to what is being done with not this one but other technologies in humans, we can typically manufacture the vaccine in 24 hours and it can be sent back out to the hospital so that the patient can almost immediately start treatment. On the T-cells, those are manufactured in under a week which is-
Kelly Scanlon:
That's really quick.
Tammie Wahaus:
Is the fastest T-cell manufacturing process we're aware of. That includes all of the ones being done by the large human pharmaceutical companies. The patient has their surgery, which in the case of osteosarcoma oftentimes is amputation, but they're ready to start treatment within a week so they can get vaccine one, two, and three, and then by week six they're getting their T-cell infusion, and then they have just a small number of supportive therapy injections that happen for two weeks.
So the patient is done with treatment, literally done with treatment in eight weeks. So what we see is dogs, when we look at the vaccine, they may get an injection site reaction, they may not. You are actually expecting to see something because you just put something in that should make the skin angry. They may feel a little bit off for 24 hours, maybe 48 hours. But essentially in our clinical trial we saw only grade one or two adverse events, which is mild to moderate, which typically then don't need any type of intervention. The dog just self gets over it. On the T-cell infusion, we actually expect them to feel a little bit off as well because we just put killer T-cell in there. That may cause them to feel a little bit lethargic. That typically would last a day to two days.
In rare cases, it does escalate in a patient and they do have to have intervention, another therapeutic, but it so far has been very rare that we see that. It would be very rare that we would see a serious adverse event. And in our large pivotal study, we didn't have any treatment-related serious adverse events. What we're doing next is looking at combinations of therapies. So we're keeping an eye on what's happening in the human health immunotherapies and we're seeing, okay, so they're putting this type of a technology with that type of a technology. And the reason we think that makes sense is, again, back to cancer being very clever and being able to evade the immune system, we think if we approach the cancer from two different mechanisms, now, if there were cells that escaped our mechanism, but maybe they won't escape the other mechanism.
So we have in-licensed in oncolytic virotherapy that is our next product in the pipeline that actually has the capability to cause a significant disruption in the tumor microenvironment where that tumor is and where it's attempting to hide-
Kelly Scanlon:
Basically double-teaming the cancer.
Tammie Wahaus:
Exactly. And then we're looking at technologies that other companies have, monoclonal antibodies that can also be paired with our technology.
Kelly Scanlon:
What role would partnerships, licensing and just collaboration with other companies play in developing your product pipeline and in your growth?
Tammie Wahaus:
We do have a loosely call them partnerships. Some of them are licensing agreements, but they're all collaborations. So I mentioned the T-cell therapy we brought into the animal health company under a licensing agreement with T-VAX Biomedical, and that technology was developed at the University of Kansas many years ago, and we have maintained that collaboration with T-VAX very closely because they have such deep scientific knowledge of the technology. We also then in-licensed the oncolytic virotherapy from a company called Genelux, and we have nice collaboration with them and they had tested their therapeutic in dogs early in their development, and then we were able to say, okay, based on how those results look, we think the combination of our two products makes a lot of sense. So they were very willing to enter into that collaboration with us and allow us to license the technology in.
And then the collaborations we have with the veterinary specialty hospitals and the university researchers, everyone wants to see better treatment options for patients. As we move forward, we're going to do the manufacturing ourselves. Some companies decide to outsource manufacturing, but for this type of product, we've made the decision we're going to manufacture it ourselves. We know how. We know how to scale it, but what we are looking to do is establish relationships with other animal health companies to, they call them co-promote agreements, but it's essentially that you have a company that has a sales force that's selling products today to veterinarians. If my product would fit nicely into their portfolio, maybe they don't want to acquire me, but they're willing to represent me. And so we're looking for relationships like that. And then we will also be looking for the opportunity to out-license the technology to non-U.S., so in Europe we'd be willing to work with someone there, Asia as well.
Kelly Scanlon:
So all sorts of opportunities for growth with these kind of collaborations. Let's talk a little bit about the future of veterinary cancer treatments. You went there a little bit, but looking forward, how do you see the landscape of cancer treatment for pets especially evolving over the next decade?
Tammie Wahaus:
Yeah, so I'm very excited about the diagnostics that are becoming available because there are a lot of dogs who don't get treatment because they are diagnosed too late in the cancer progression. And so I'm excited about the work that the diagnostics companies are doing to be able to get an affordable diagnostic that can be included in an annual checkup.
Kelly Scanlon:
Let's talk about your location here in the Bioscience Corridor, it's extends from Manhattan, Kansas all the way to Columbia, Missouri. You mentioned the University of Missouri earlier. How has being located within that corridor allowed you to grow to move faster?
Tammie Wahaus:
Well, obviously, had I not been in the corridor, I wouldn't have had the opportunity to so quickly meet the head of the oncology department who became ultimately the dean of the vet school, and then in Missouri and then also turn around, I'm a K-State grad and turn around and look at the K-State Vet School and say, will you guys talk to me? I was able to have meetings with the dean of the vet school and the head of the oncology program at Kansas State University. I think that speaks of what we know about this Midwest region. You call up the dean of the vet school or the former dean of the vet school and you get through.
Kelly Scanlon:
The accessibility. Yeah. Exactly.
Tammie Wahaus:
Yeah. And then because of the work that the corridor does and brings investors and companies and large and small companies to the community every year with the summit, I was able to meet people that I wouldn't have otherwise even knew existed. And then of course, the USDA, the agency we work with, the Center for Veterinary Biologics is just up in Ames, Iowa. It's like three hours away.
Kelly Scanlon:
Everything is really just it's windshield time.
Tammie Wahaus:
Yes.
Kelly Scanlon:
To get on a plane to go somewhere. Yeah.
Tammie Wahaus:
Right. And people really want to help. People really want to see the animal health community bring better solutions, whether it's livestock or companion animal or production. This community really wants to see the advancement of technologies. And I've always said, great ideas can come from anywhere. You don't have to be on the coast to have the best idea.
Kelly Scanlon:
As a leader, someone who is guiding a team of people through all of the different things that you just discussed, how do you foster a culture of innovation? How do you keep the dedication and the morale high when you're going through these clinical trials? And maybe, well, you mentioned the whole COVID thing, when things are not going according to the timeline and just it's demanding. Cancer research is demanding. As a leader, how do you keep your team engaged and thinking ahead?
Tammie Wahaus:
One of the skills that I look for in people, and I don't know if this makes sense to others, but I look for people who can see around the corner. The issue we're dealing with today, I need you to think two or three steps. If we make this decision, what could happen and which of those things can we not live with or not recover from, or would be our most desirable outcome? And so let's fix our odds so that we get the best desirable outcome. But you got to be able to anticipate what could happen next and will that be good or bad. And so assembling a team like that and then really valuing their opinions. All the time, we talk about, well, what could go wrong? We need to do this. What could go wrong? And that's the auditor in me. That's the standard question, what could go wrong?
And then we talk about all those things and then we figure out how to manage the risk. I think also really valuing your employees' opinions, not just your direct reports, but the entire organization because you're a small organization and everybody sees a different piece of it. So really valuing their opinions. I ask questions until I understand it, and some people don't like that, but on my team, we find it to be very effective. And my philosophy there is, if I don't understand what you're saying, what you're recommending, then you have some more work to do to be able to explain it to me in a way that I can understand it. And that gives me confidence that you really know this. If you can translate it to me.
We have these conversations all the time with my chief medical officer who's a veterinarian, and he will rattle off some eight syllable medical term. And I just have to say, I don't know what that is. And I can't Google it because I don't know how to spell it. So talk to me where I'm at and then find our common ground. And that has worked really well.
The other piece that I would really encourage people to do is always remember to focus on the customer. Focus on the customer. And if you can delight the customer, and in our case, is a dog a customer? Well, he doesn't pay, but he benefits. Is the pet owner of the customer? Well, they are paying, but they're not our direct customer. The veterinarian, he's or she is our direct customer. They're the ones who are going to pay for the product and then charge it on to the pet owner. We have to delight all of those people and focus on the customer at every turn, in every decision. And if it's right for the customer, it will ultimately be right for the firm.
Kelly Scanlon:
Tammie, thank you so much for coming on today and explaining this in really understandable language. What an exciting time to be in cancer research. So thank you for sharing with us and we wish you the best.
Tammie Wahaus:
Thank you.
Joe Close:
This is Joe Close, president of Country Club Bank. Thank you to Tammie Wahaus for being our guest on this episode of Banking on KC. Tammie's entrepreneurial journey from analyzing complex financials at Ernst & Young to ownership of a biotech startup was a major leap in many ways, but as she notes, it illustrates the dynamic interplay of skills and sectors that have led to groundbreaking solutions in veterinary medicine, particularly in cancer treatment for companion animals. ELIAS Animal Health's focus on personalized immune-based treatments showcases how Kansas City's spirit of innovation is making significant contributions to both human and animal well-being. The work of Tammie and her team is a testament to Kansas City's growing influence in the biosciences sector. Thanks for tuning in this week. We're banking on New Kansas City, Country Club Bank, member FDIC.