Lacerta Therapeutics

Lacerta Therapeutics is a clinical-stage gene therapy company focused on the development of treatments for neuromuscular diseases. The primary goals of a gene-based therapy approach are to directly restore the function of a faulty gene, block the toxicity of a mutant gene or deliver gene-based therapeutic relief. Lacerta Therapeutics is developing proprietary, viral-based approaches to deliver gene therapies to treat incurable diseases. Lacerta is also developing next-generation gene therapy manufacturing technologies in an effort to lower costs and expand access.

FOUNDED IN

2017

INDUSTRY

Scientific Research and Development

COUNTY

Alachua County

REVENUE

2291% increase from
2017 – 2020

EMPLOYEE GROWTH

180% increase from
2017 – 2020

Edgardo Rodriguez

CEO/CSO

Can you tell me a little bit about your background? What led you to Lacerta?

I am originally from Puerto Rico and chose to pursue my PhD at the University of Florida because of their expertise in AAV gene therapy. This was back in 1999 and even then, I felt this technology had such huge potential and promise.

While attending graduate school at UF, I trained under the supervision of Faculty who I believe are truly the pioneers of AAV gene therapy. I continued my career development and I left Florida for additional training. I returned to UF as a member of the Faculty in the College of Medicine and when I came back, the same guys that had trained me were now thinking about starting up a company that became Lacerta. I was Lacerta’s founding Chief Scientific Officer, before being appointed as President and Chief Executive Officer. Being a co-founder of Lacerta provided me with the opportunity to explore my first entrepreneurship experience. It has quickly become my passion and I have really pushed hard to continue to find success in the company.

Did you always know you wanted to be an entrepreneur?

I have always viewed myself as a leader, but I do not come from a business family background, I come from a background in medicine and academics. So, it is easy to see how I ended up as a Faculty member in the College of Medicine. Entrepreneurship wasn’t really an ambition of mine going through college, but it’s amazing how true it is that when you find exactly what you want to do as a professional, it rarely feels like work. That’s what I’m experiencing right now. In my current role as CEO of a small biotech company, I get to use every one of my skills, and I get to develop new ones. I love it! That’s really the passion that I have for entrepreneurship and now this company.

Can you tell me a bit more about the company and the value you guys bring to your customers?

Lacerta Therapeutics is a gene therapy company focused on the development of treatments for diseases of the central nervous system. These include neuromuscular disorders, neurodegenerative diseases, and neuro-oncological indications. The primary goal of a gene-based therapy approach is to directly restore the function of a faulty gene, block the toxicity of a mutant gene or deliver gene-based medicinal symptomatic relief. Lacerta Therapeutics is considered an early or preclinical stage gene therapy company.

We are developing proprietary, viral-based (AAV virus) approaches to deliver gene therapies to treat incurable diseases. We are also innovators in the manufacturing side of it. This technology right now has a huge amount of potential that is being held back by the inability to manufacture these products at scale and with efficiency. The current methods cost a lot of capital and unfortunately, that cost must be passed down all the way to the price of drugs that are approved. We’re developing next-generation gene therapy manufacturing technologies to lower costs and expand access. Our goal is to make sure that at the end, this technology is accessible to all who can benefit from it. That’s personally important to me as a member of a minority race.

Our expertise in AAV technology has been validated by the partnerships we have established across Pharma. Our partners make use of and benefit from our expertise. In return, we benefit from their infrastructure and their expertise in bringing drugs from concept to the market.

What is the process to get everything approved?

Right now, for most of our programs, our timeline is to be a full clinical company by the start of 2024. At the start of 2024, we should be in the clinic for at least two different products. After that, it’s a process of about 6-8 years before we can see a drug be approved by the FDA for commercialization.

How do you stay ahead of your competition?

This space exploded around 2018, it’s very competitive. Once investors started to understand the potential of the technology, a lot of different capital was brought in, which then led to the formation of many companies. There are several companies just like ours that are either in the preclinical stage or early clinical stage. We think because our roots are from the University of Florida which is where this technology was born, we have a clear technical advantage over our competitors and a pronounced differentiation across our products and platforms. Innovation and technical expertise form the foundation on which we are building.

Tell us a bit more about the culture of your organization.

This team is first and foremost a family. To me, that is a key part of the culture and how I lead the company. It is also how I expect my managers to work with their teams. It is a company that believes in an egalitarian principle – we want every single individual in this company, not only to contribute but to equally share in the rewards that are brought about with our successes.  

It’s a priority for us to continue to grow our culture when we’re at work, and outside of the company. I first took the helm of the company at the end of 2020 and, throughout last year, the company expanded and grew from 20 employees to 54 employees. Our turnover is practically zero and this is important to us because our success as an enterprise is dependent on recruiting and retaining a highly-skilled, technically savvy workforce.

Are you able to recruit in-state or do you hire out of state?

Our proximity to the University of Florida, which is where this technology was born, really helps us be able to recruit elite talent. In addition, Santa Fe College, which has always been ranked one of the top community colleges in the state of Florida, has a fantastic biotech program. That’s just down the road from where we are. We get access to the students as interns very early on. For a company like ours, we’re so focused on early-stage and innovation, I think we’re well-positioned to continue to feed off the talent that is coming out of those institutions.

But we have also been successful in recruiting talent from out of the state to Alachua as well, believe it or not. Where we sometimes face challenges is in the senior management positions – the people who are more established in their careers and are drawn to cities like Boston, Philadelphia or Chicago. Those tend to be more difficult to recruit to this area.

What are some of the goals you have for your company?

A primary goal for us is to see more than one of our products reach clinical-stage and hopefully get the safety and efficacy signals needed to push forward. These therapies are desperately needed by the patient populations that we are targeting. To me, that is the number one goal of the company, and everybody here is working towards that. We engage with patients and patient advocacy groups and have them come visit us here at the company. This helps raise awareness and generates enthusiasm and inspiration to do this hard work.

The second goal is to continue innovating and pursue strategic opportunities with large Contract Drug Manufacturing Organizations in order to deploy our technologies across the entire space. I believe that by showcasing our technologies and establishing newer partnerships, Lacerta will play a key role in the future growth of the area. We want to see the Gainesville/Alachua continue to grow because we believe it will have a positive impact on the recruitment of senior management, for example. I think that would be welcomed, not just by us but also other biotech in the area.

My last goal is that five years from now, I can look around the company and see that my current employees – the ones that are in the trenches with us right now – will still be there with us to celebrate future key clinical development milestones.

Do you have a proudest moment as a co-founder?

I think my proudest moment so far is the recent agreement that we signed with UCB Biopharma, which is a pharmaceutical company in Belgium. That agreement was based on technology that I have been working on since I was doing my postdoctoral training. As a co-founder, I was very proud because it was my contribution to the company. It led us to be able to have an agreement with a large pharmaceutical company and now we have a partner that’s helping us bring that science into reality and turn it into an actual drug product.

What does it mean to you to be selected as an honoree this year?

To us, it means that we have cemented our place as a biotech company that is pushing hard on the boundaries of innovation. It means that the hard work that we put in as scientists is now being recognized by our peers. At the end of the day, it is really the science and our capacity to innovate that allows us to be a successful business. We’re not trying to be a successful business, independent of science. Our focus is on our scientific core principles and that has allowed us to prosper.

Is there anyone you would like to thank?

All of the scientific co-founders of this company have been extremely gracious with their time and their commitment to helping. I am extremely grateful to all of them, not only because of their contributions but also because of their trust in my leadership.

My advice to aspiring entrepreneurs is…

"Make sure that you are focused on making the best product that you can. You may have those times when things just feel desperate, but it's the quality of what you work on and the quality of that product that's going to get you through to the other side. Secondly, having partners that can see and appreciate the quality of your work is extremely important, especially when you are in a competitive space."

Celebrate with the Lacerta Therapeutics​ team!

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