Torigen | Kisaco Research

Founder Journey

with Founder and CEO Ashley Kalinauskus

2022 EU Innovation Showcase Finalist
We recently followed up with 2022 EU Innovation Spotlight Finalist Ashley Kalinauskus to get an update on Torigen’s incredible progress, not least of which is the facility that will provide 10x room to grow. Full interview below the video.
4 October, 2023
1st Follow-up: Since we last spoke...

Could you provide a recap on your technology and what the biggest changes have been for you since we last spoke towards the end of 2022?

Torigen is a veterinary therapeutics company located in Farmington, Connecticut. The current product that we have is a personalized cancer vaccine that's created after a tumor is surgically excised at a veterinary clinic and then is submitted into our office here in Connecticut. Once that tumor sample arrives at our laboratory, we work with third parties to confirm the diagnosis of exactly what's going on with that patient. If that comes back as a malignant cancer, then that veterinarian has the option to order our autologous prescription product.

...we've in-licensed new technology that we're very excited about that will help bring us into some of the biggest key problems in animal health

It's our personalized cancer vaccine that utilizes the patient's own tumor cells as the antigenic backbone for a personalized therapy. Providing clinics with this option that they just haven’t had before has provided a really nice growth trajectory over the last year.

One of our main pivots as a company has been how can we expand ourselves outside of the cancer therapeutic space and really become a leading animal health company. So, with that, we've in-licensed new technology that we're very excited about that will help bring us into some of the biggest key problems in animal health, atopic dermatitis, KCS and IBD.

 




How did you make the decision to focus on these new areas? How has the translation between human and animal health shaped this opportunity?

Our cancer product was really based off the technology that we had, which myself and my former professor, Dr. Mark Suckow, had launched out of my grad student thesis from the University of Notre Dame. With that, we had this amazing cancer vaccine technology that we knew had an opportunity to make a really big impact. When it comes to these other autoimmune based diseases, the new asset we brought into is able to stop autoimmune diseases in their track by targeting specific immune cells to stop the inflammatory release of those cytokines. So, for us, it really came down to the preclinical data highlighting and showcasing that there was a strong opportunity here, followed by the clinical data, showcasing a really great safety profile, and then some preliminary efficacy data supporting our ability to unlock these really large potential markets.

This asset came out of the human side. A lot of the same steps that have to be completed for IND approval on the human side are some of the same preclinical and clinical steps that are needed on the animal health side. Our approach was to think about how we can repackage this data as an opportunity to really support the veterinary commercial launch because some of the preliminary data had already been conducted. From my perspective as a small startup company, being able to showcase and see that the data was strong and that there was a potential commercial application here really was exciting for us and for our team.

We've had a lot of conversations where biotech investors eyes will light up when we highlight they may have some huge opportunities where they can leverage a therapy in their portfolio over into animal health. But I've yet to bring on an investor who has opened up their asset portfolio in order for us to really get deep enough and understand if that asset does have applicability in animal health. There are a lot of things that must be evaluated. We need to know the target and look at the preclinical data. But our team can absolutely do that. So, I see a lot of eyes lighting up, but I haven't had anyone bite on it just yet, so I'm hoping that'll change with this next round.

Human companies are generally laser focused on advancing their therapeutic into the clinic. Every ounce of focus has to go there, but I also think that there's this fear of what if it launches in animal health and it fails? Will that be a black mark against the human product? Or what if it gets launched into animal health and there's severe adverse event and could that translate over to human side? But, historically on the animal health side, we've not seen that happen. We've never seen a human health drug get pulled because of bad animal data. We've also never seen an adverse event in dogs land on a human health label as far as I am aware.

I think that potential risk is low, but it’s a fear that’s still present at both the investor and human biotech level. I would say the bigger risk that the human investors do see is pricing. How do we price it for humans a thousand times higher than we're pricing it for dogs? One solution would be to switch out that API over into a new company like our company and being able to separate everything. You can have this huge separation where the only thing that needs to pass through is data and nothing else. I think it's going to take a little bit more time before human health companies will really understand that, but I do think there's just this world of possibility to bring these advanced therapeutics over to veterinary health.

...there's just this world of possibility to bring these advanced therapeutics over to veterinary health.

What’s allowed us to work with these assets from human biotechs has been our ability to validate that the target is an actionable target within dogs or cats. Plus, we've traditionally been dealing with kind of earlier scale human assets, who are going through IND approval or into their phase one studies because that's when they have that canine data. We're not dealing with the phase three approval drugs that have already raised 400 million, it’s more the companies that have raised about 20 million, so I think they can relate to us more easily. I would love to see there be a continual replication of this cycle because we're having fun doing it.



What have been the key operational changes you’ve made to support your commercialization journey?

There are two sides of this. From the commercialization side of course there had to be a scale up in our approach. We had our R&D and product development based at the University of Connecticut Health Center and our manufacturing lab with a small clean room inside. Up until a year ago, that's where we fully manufactured. There was an opportunity to grow and build out our own space that would support a larger number of the cancer vaccines. So, we moved down the road a few miles in Farmington, built out our own large clean room, our manufacturing facility, a beautiful office as well for the team to grow into. Outside of having to learn way more about the HVAC required to support clean rooms than I ever expected to, this transition has gone pretty smoothly.

There was an opportunity to grow and build out our own space that would support a larger number of the cancer vaccines.

One thing that fuels the need for operational scale up is the commercial side. In veterinary medicine we have this bifurcation of how to tackle the veterinary market. You have all these independent small practices and large corporate groups, so there must be a kind of multimodal approach. The larger AH companies have the manpower and the capital to do that, but it’s a lot harder for a smaller company. But we're not selling a product, we’re providing a service to the veterinarian and that fundamental shift really leverages the fact that we need to educate more of the veterinary community about cancer and have everybody feeling comfortable after a cancer diagnosis is provided. The fact is, so few pets go onwards to see a veterinary oncologist after their diagnosis, whether it's the distance or the potential cost, so, then it becomes, well, now what? Outside of steroids or comfort care measures and surgery, there are no other options within general practice. So that's really where this cancer vaccine and our personalized immunotherapy can be positioned as another option for the owner to consider after that tumor has been surgically excised.

Our team has two board certified veterinary oncologists on our staff. Dr. Mike Lucroy is our Chief Medical Officer, and Dr. Chelsea Greenberg is our Vice President of Veterinary Affairs. Both of them support our clinical studies and work with veterinary clinics in order to discuss what the best option would be for that patient. We’re the first ones to raise our hands to say, hey, this is really not the best patient for us for this variety of reasons. But on the flip side, if this is a patient that there could potentially be a benefit by utilizing this vaccine, then we want to be there in order to provide that option. So going back to that channel versus individual clinic approach, because we have such a compelling story and because we're able to provide such an educational experience for the veterinary community, we're able to get through the gatekeeper and we're able to have a small number of boots on the ground to help us tell that story better.

We aim to amplify that by leveraging some channel partnerships as well. This year we signed a preferred partnership with Veterinary Management Group (VMG) and we're getting together with some of their industry groups helping educate them about the options they have after a cancer diagnosis, and really positioning the cancer vaccine as another tool in their toolkit that can be considered if necessary.

This year we signed a preferred partnership with Veterinary Management Group (VMG)

Having a great team, who are backed up by this value proposition of educating the clinics on immunotherapy and other options, as well as providing resources back to their practice in order to help them understand some of these cancer cases that are coming in. I think that in itself has really elevated us as more of a thought leader, and I know from my team, they really love being in that position because they’re able to answer the questions and they don't want to do the traditional product sales cycle anymore. They want to be able to really help solve a problem and cancer's a problem that needs to be solved.



What’s contributed to you being able to build a great team?

I received a great compliment today around my willingness to be open and learn and to really share my excitement about what we're doing. I think it comes back to the fact that I'm not a traditional CEO, I've never done this before. I was a grad student who had an idea who took the technology that she was working on and commercialized it out. I've been through all the stages of building this company and really understand who I want around me as I grow this company. Identifying exactly who those people are that you need to support you at each stage. As a founder you need to ensure you're placing the responsibility for the company in the hands of people that are smarter than you, with industry leading experts who know so much more than I ever will at this point in my life and career to help elevate the business. By doing that, it helps elevate myself too. Asking them to then go seek out people even smarter than they are, bringing together collaborative people who are kind, who want to do what's best for the betterment of this company, helps build out this really strong collaborative network where no one is afraid to ask the question or say, I don't know. By doing that, it’s built this awesome culture where we all work together and if we don’t know the answer, we might know someone who does, so lets go get them on the phone. It's that kindness and that humbleness that has really helped elevate us as a team.

I was a grad student who had an idea who took the technology that she was working on and commercialized it out.


Raising capital can be a full-time job for founders, how have you approached that process?

My investors have typically known me for years prior to them being investors in the company, quite often because I asked them for money initially and they said no – this was the starting point for many of these relationships. No isn't a door shut in your face, a no is a, hey, circle back with me when you are done de-risking it, because what you're dealing with right now might be a little too risky for our taste. I’m open and transparent with the steps we’ve taken and progress we’ve made and that’s really helped showcase what we’ve accomplished in a relatively short period of time. I have a few investment groups that are currently completing due diligence on us that were groups that said no in the past but are really excited about the progress that we've made to date, which is fantastic. However, with this series B, I do want to take more of an institutional approach of releasing it out to as many investors as we can, taking the meetings, being able to have a set deadline as to when I'm looking to have term sheets and able to raise that capital. This will help provide more excitement around our raise as well. I think we have an extremely exciting company, and I think it deserves that.

No isn't a door shut in your face, a no is a, hey, circle back with me when you are done de-risking it

The low and slow relationship building approach I think served us very well as we've gone through the past couple of years. But now I really want it to be kind of more of that feeding frenzy of like, wait, wait, wait, if we give her more capital, she has a repeatable business model and more products coming and they have this amazing team and they could probably keep doing it again and again. Let's listen and let's understand how we can do it. The capital markets are hard out there right now and I haven't entered it quite yet, but we will in the coming weeks.

Early days are always hard, but I've also felt that I've been drastically underfunded throughout most of this business. I want to go out with a number that provides us the opportunity to get done as much as we can and to get to cash flow positive all in one scoop.

One of our lead investors has had multiple exits within animal health and loves to play in this space, so that for me checks all my boxes. My other investors are biotech, so maybe traditionally more human biotech or device biotech, but are interested on the animal health side as a potential faster route of commercialization. I have one investor that's growth focused, so it is growth stage equity capital that's meant to provide a sizable return, which is fabulous. And then I've also had one other investment group that's for women-led founders and women-led investors. It's been a mix as to who we can attract but that’s left us with a really strong group of investors who have both the biotech experience as well as the founder and entrepreneurship experience so that we can really bring the company up to the next level.

 


When it comes to raising or deploying capital anything that you would've done differently?

Everything takes twice as long and costs four times as much. If I were to do it again, I would've raised more money earlier.

From 2019 up until end of 2022, it was a continuous raise. That part in and of itself was pretty hard, so I really only got to focus on the business for a couple of months this year, and now it's back to the raise. If I were to have raised more, I probably could have focused more on the business, being a founder, a CEO, a former researcher and also more time as a really great storyteller about our business. I’m a great asset to this company across many different levels and getting more time back in my day, this could potentially have put us even further ahead than we are.


What do the next 12 months have in store for you?

Series B, capital raise, between 15 to 20 million dollars.

This raise will help support the launch of our clinical studies for our new product lines for atopic dermatitis as well as KCS and potentially IBD. Plus, we want to finalize and complete our last study for our cancer vaccine conditional licensure with the USDA.


What personal attributes do you feel have contributed to your success to date?

I just came back from a great session where they brought a bunch of entrepreneurs together and then we ‘unlocked our genius’ and identified what we were the best in more than anybody else. It taught you a lot about your values and your decision-making framework. For me, one could say I'm a jack of all trades, but what I’m the best at was that I built this incredible team. Going back to my earlier point, I’ve always looked to hire folks better and smarter than me, so I'm not the best at anything on any given day. But what I am a genius in is being a mover and a shaker within the company, of being able to ask the right questions, dig deep, bring in the right experts, the right expertise and making sure that everything is always moving up and up on a linear path. Working out what your genius is a useful exercise for every founder.

I’ve always looked to hire folks better and smarter than me, so I'm not the best at anything on any given day.

The thing that I hate the most is failure. But on the flip side of my genius sometimes I can be conflict averse in my attempt to avoid failure. Maybe I don't want to have that hard conversation with an employee or maybe I do see them slipping and I'm like, I don't have time to address that, I'm just going to wait a little bit. With this next raise another hire that I would love to make would be a Head of HR to look after our team of 30. Right now, I’m effectively the head of HR and I’m conflict averse. I've never been a CEO before, never been a company leader before. I think I'm doing a good job, but I've got no benchmarks. But I think that introspection for me to understand how I can continually do better, can help build my business to be in a better place too. Also, I typically know in my gut what the best way to move forward is and intrinsically always want to be moving the business forward. That's what makes me happy and makes me ‘me’, but I try and be consultative with a lot of decision making and I do appreciate that empathy that I have for my team, and that makes me a good leader because of that. But at the same time, if that's slowing me down and I'm not able to move things forward, maybe there are times where I just need to let everyone know, I'm just going to do it this way.

12 October, 2022
Original Interview

Can you tell us about yourself and the story behind Torigen?

My name is Ashley Kalinauskas I’m the founder and CEO, and the idea for Torigen came from my graduate research at the University of Notre Dame. The professor that I worked alongside had developed a way of creating personalized cancer vaccines utilizing a portion of the patient’s surgically resected tumor.

tumors become the antigen backbone for the creation of an autologous cancer vaccine

That tumors become the antigen backbone for the creation of an autologous cancer vaccine. We had patents, publications, and strong data. What we decided to do was, instead of thinking and focusing on the human market, to think critically about the veterinary market – more specifically dogs, cats, and horses after a cancer diagnosis.

Up to 6 million dogs each year are diagnosed with cancer, and so few go onward to get treated with chemotherapy or radiation therapy. We thought this would be an amazing market for us to spearhead initially.

We have the product available for sale in the United States and work with about 500 veterinary clinics nationwide. For us, it’s about being able to grow that product and adoption, but we’re also focused on developing a pipeline of additional therapeutics. So, we have a second version of our vaccine that is in safety testing now.

We’ve also partnered with human oncology companies to enlighten some novel assets for the veterinary market. We’ve chosen the animal health market because of the overall cost associated, the clinical development of the therapies, and for wanting to be able to make a difference faster.


What would you say were the biggest stresses you feel as a founder?

Everything. I truly love the animal health industry, and I love the connections that our team and our company have been able to form within the industry. Everyone is helpful and collaborative, but I would say that one of the biggest stressors is financing and raising capital.

Of course, human investment companies for human biotech are a dime a dozen. But when you focus on animal health, they tend to see that as a niche and not as much of a widespread opportunity to come to fruition. We’ve seen so many successful animal health companies get acquired by large players, but there are not that many of them and you really must fit, lock and key nicely into their acquisition strategy. Financing is also one of the stressors that every early-stage company, including ours, deals with.


How do you measure success?

The adoption of our personalized cancer vaccine in the veterinary market is a big metric for us, as well as the revenue associated with that. Also raising capital is another as building out our pipeline. It’s about understanding the future potential of some of the assets that we’re working on through the de-risking phase and moving into a larger clinical phase as well.

For me, it is ending this year on a good revenue trajectory, as well as the strong asset pipeline that we’ve brought in will be amazing. There’s a lot to do.


Have there been any pivot points in the company’s lifetime?

One of the most interesting pivots is one that we’re coming back around to. Initially, when we launched the business for our personalized cancer vaccine, we were thinking that it could be a product that could be made within the veterinary practice itself. It started as a kit that we would provide to veterinary clinics to make the therapy in-office.

We decided to pivot away from that and go to a model where we manufacture the vaccine ourselves to have more control over the environment and product quality control. However, we believe that internationally, the kit could be positioned as a successful product.

We initially pivoted away from the kit and now we’re pivoting back to the kit for international markets, and we’re excited about it.


Were there any moments when you thought it was all over?

There are plenty of times. A startup company is a rollercoaster. It’s the highest of highs and the lowest of lows. You must find ways to weather that storm because it keeps coming and over time you become more resilient to those.

At times it feels like the whole world is crashing down, but it comes down to every business having problems. You need to have a solution and a market; that’s what we had. By resting on our convictions of knowing so many dogs have untreated cancer and us having personalized immunotherapy that can help. We have a market that can support this.

The hardest part was raising the initial capital to get this up and running.

The hardest part was raising the initial capital to get this up and running. Then, once that happened, everything started falling into place. The team, drive, manufacturing, marketing; all those pieces started to come together and that’s how a business is formed.


Can you tell me more about your experience with fundraising?

The first round is always the hardest. We raised it from our team. My former professor was one of the first investors and the University of Notre Dame. The University of Connecticut and Connecticut Innovations were our initial investors as well. We got off the ground by focusing on university and state-based funding.

Hopefully, by the next couple of weeks, we’ll be able to announce the closing of a significant round for us. We started this process in August of last year. We’ve been raising money consecutively for over a year now and I’m excited to finally see the end in sight.

By starting as early as we did, we still have the runway, and it allowed us to do two closes of the round. We made connections with our investors this time last year through the investor network.


What advice would you give other founders in the field?

I think that it’s about forming great connections and being able to build on those. You’re not alone. You’re walking in the footsteps that someone else forged already. Being able to rely on mentorship and advice can transform where you’re going.

Running a startup company is not easy by any means, regardless of the industry. Having strong mentors, both within the industry and outside of it is extremely important to facilitate growth.

I always use the rule of threes. If someone tells you something you might not want to hear, go to another two people. If those two people say the same thing, then you have to change your perspective

You should have multiple pieces of advice to bounce around and understand whether someone is saying the truth and if other people have the same opinion. We all hear the horror stories of the Silicon Valley founders so focused on always being right. Unfortunately, that’s typically not how this works. You have to go out and talk to your customers and mentors in the industry. You have to be able to take advice, leave advice and take the next step forward as you see fit.

I always use the rule of threes. If someone tells you something you might not want to hear, go to another two people. If those two people say the same thing, then you have to change your perspective on it, which is fine.

Another thing that I found has been helpful for me is I’m part of a founder therapy group called “Founders Without Burnout.”

We are all CEOs of venture-backed companies and we come together – in something industry agnostic – to talk about some of the challenges we’re facing daily, weekly, or monthly basis.

It’s funny because it doesn’t matter what industry we are part of, we have the same problems. Problems with employees, fundraising, investors, and preparing for the board. We get to understand what our next steps are. It’s also a way of feeling support because this is a lonely journey.

In an early-stage business you have to be extremely resilient, but you also have to ask for help when you need it. I think it comes full circle. We talk about this in our group; we are there because we want to understand and recognize we want to be the best version of ourselves, and we want to build the best possible company.

I like looking at other women who have laid some amazing groundwork. Linda Rhodes with Aratana, Denise Bevers with Kindred, and Kristin Peck now with Zoetis.


Which other founders and leaders in the market inspire you?

I like looking at other women who have laid some amazing groundwork. Linda Rhodes with Aratana, Denise Bevers with Kindred, and Kristin Peck now with Zoetis. Those are three women that I look up to in terms of how they’ve been able to lay the foundation for women moving forward into executive-level roles at some of the large animal health companies.

I would love to build one of the next large animal health companies and, you know, be able to see what the trajectory and future hold, not only for this business but for my future growth potential as well.


What changes would you like to see in the animal health market?

I would always love to see more women around the boardroom table and be able to support each other with growth. I think we’re such a unique group in the animal health industry, but we’re all focused on being able to help each other. Those founders are not my competitors and if I can provide them – or an investor that might have said no to us – with a nugget of information and change their minds to a yes, then it's worth it. We’re an open book to help each order to make this industry grow and succeed.

Of course, I would love to see more funding come the way for animal health. To do that, we’d need the big four and the second-tier large animal health companies to start making investments or acquiring earlier-stage companies.

It can help fuel investor returns, so you’re able to make bets on early-stage products and would be able to see them advance in the market. The more acquisitions that happen, the more funding that could be further fueled into more early-stage companies that you can build out your asset portfolio pipeline a lot easier and better.

In the human medical device sector, some of the major device companies are focused on providing investor returns as well, because they know if they provide it, they can know if one product is not as good of fuel for future revenue, while another one of them could be a blockbuster.

Lastly, veterinarian and vet clinics have gone through massive consolidation lately, which is phenomenal for the industry but it’s also hard and challenging to sell into a veterinary clinic. Finding different or more innovative sales channels could be an interesting opportunity for the industry.


Torigen Pharmaceuticals is a US company that is developing advanced cancer care solutions for companion animals through personalized cancer tissue vaccines.

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