Dr. Linda Black | CEO of Gallant

Dr. Linda Black is the CEO of Gallant, a pioneering animal health biotechnology company developing off-the-shelf stem cell therapies for pets. With more than 18 years of experience across biotechnology, regenerative medicine, and veterinary science, she has led R&D, operations, and clinical development at companies including VetStem Biopharma, Medicus Biosciences, and SciStem Therapeutics.

In this interview, Dr. Black shares her path from veterinary medicine to biotech, what it takes to build an entirely new regulatory category, how Gallant is scaling regenerative therapies for real-world veterinary use, and why compassionate leadership has been central to the company’s progress.

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After earning your DVM, you chose to go even deeper into science through research and a PhD, and eventually focus on regenerative medicine. What inspired you to transition from clinical veterinary practice to biotechnology and stem cells?

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During veterinary school, I also worked in a research lab, where I discovered I loved science just as much as clinical work. The why of disease, the mechanisms, the opportunity to develop therapies by understanding the biology behind the disease — I loved research, and it turned out I was also good at it. That’s why I pursued a residency in comparative medicine and then completed a PhD in cell and molecular biology.

I thought I would build a career as a basic cancer biologist, whether in humans or animals.

Everything changed when I had my son and couldn’t bear leaving him to do a postdoc after my PhD. So for a few years, I stayed home and ran a science writing business so I could remain in the workforce while caring for him.

Then, when he was a bit older, I joined a veterinary biotech company, working on early research in regenerative medicine for pets. I had the opportunity to lead clinical trials using stem cells to treat osteoarthritis in dogs. When you see those results firsthand — an older dog chasing tennis balls like a puppy again, moving freely and living without pain thanks to a treatment you helped shape — it’s life-changing.

That’s when I fell in love with regenerative medicine.

Stem cells are the body’s natural healing mechanism. They are in almost all tissues of the body. When you cut your arm, it’s stem cells that orchestrate the healing.

They detect damage, home to the injury site, interact with immune cells, and secrete factors that orchestrate healing, like the body’s own skilled emergency response team that senses trouble, rushes to the scene, coordinates with local workers, and provides tools to help heal. It’s a divinely coordinated system.

We then harvest stem cells, in our case from the uterus (a tissue that is thrown away during a spay procedure), grow them into millions of doses that can be given back to a dog or a cat to help their ailment and they work in the very same way, to restore and regenerate tissue.

The idea that we are harnessing the body’s natural healing mechanism to create a medicine to reclaim health still inspires me every day. I love it.

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You stepped into the CEO position at Gallant during a very difficult time after the founder’s passing. Can you share what that transition was like for you personally and professionally, and how it shaped your vision for the company moving forward?

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Aaron Hirschhorn wasn’t just the founder of Gallant. He was my business partner and friend. His death in 2021 was a personal and professional loss for me.

From the beginning, Aaron and I built the company together — he raised the capital, and I built the business in San Diego. When he passed, I went overnight from having one big job to two. Suddenly, I was not only running the company, I was responsible for fundraising as well. It was a lot to learn, and it came at a time of grief.

Strategically, our mission never wavered. From day one, our goal was to take stem cell therapy, a solution once reserved for the elite or for human medicine, and make it accessible to all pets. All along, we had been developing two pillars: stem cell banking and off-the-shelf therapeutics.

After Aaron’s passing, we made the decision to target our resources where we believed we could make the greatest impact — accelerating the development of off-the-shelf, allogeneic stem cell therapies and bringing them into everyday veterinary practice.

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You’ve emphasized the importance of compassionate leadership and emotional intelligence in building Gallant's culture. Can you share a specific instance where leading with empathy directly influenced a pivotal decision or outcome at the company?

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I think it starts with the idea that people come first. I believe that if you care about people first, it's much easier to execute your business plan, and it’s more fun.

From the beginning at Gallant, the goal has been to build a culture where every person knows they are valued as human beings, and we are all in this big endeavor together. We know from Travis Bradberry that 90% of top performers have high EQ, and this comes into play at every meeting, every interaction, every day.

Having empathy, being able to place yourself in the other’s shoes, solves a lot of potential relational problems before they start. We’re a group of strong, smart, type-A women (mostly) doing something that’s never been done before.

That brings lots of challenges, opinions, and passion as we push aggressively toward our goal of bringing the first FDA-approved stem cell therapy to the market.

Trust me when I say, it goes much smoother when the people around the table are self-aware, have high empathy, and can communicate from a place of understanding emotions.

This paradigm builds trust and connection, and when you pair that with a mission people are passionate about, like stem cell therapy, it creates supernatural results. It’s the reason that, after only six years, after starting from scratch, we are on track to have potentially the first stem cell therapy get through the FDA process.

Compassionate leadership, to me, means putting people first while at the same time keeping the bar very high and holding all our leaders to that standard. We set high standards for excellence in everything we do, from our science to manufacturing, to clinical trial design and execution, to investor relations and stakeholder communications. It’s been a winning strategy for us.

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Can you explain what “off-the-shelf stem cell therapies” means and how this can help pets suffering from debilitating diseases?

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Off-the-shelf stem cell therapy means the treatment is already made, frozen, and ready to go when a pet needs it.

For a long time, the only option was what we call the old way: autologous stem cell therapy. That meant taking tissue, usually fat, from the pet, sending it to a lab to isolate stem cells, and then returning it as a custom-made dose for that same animal. It required surgery, lab processing, and at least two vet visits. It was expensive, slow, and just not practical for most families or clinics.

The new way is different. Instead of harvesting cells from every individual patient, we use stem cells from the uterus of a single, healthy, FDA-qualified donor and grow those cells into tens of millions of doses. The cells are frozen and ready to use when needed, administered intravenously, as simply as giving IV fluids. That’s ready-to-use, off-the-shelf treatment.

This approach is not only more accessible, it's also easily scalable. It removes the barriers of cost, time, and complexity, making regenerative medicine something that will be as routine as giving a vaccine. That’s the future we’re working to make real.

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What has it been like navigating the regulatory landscape in veterinary biotech? Have there been any surprising challenges or advantages along the way?

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Anytime you're working in a regulated space, things naturally take more time and investment — but to us, that’s not a drawback, it’s a responsibility.

At Gallant, we're not just developing therapies, we’re creating an entirely new category within veterinary medicine. Because there are no FDA-approved stem cell therapies yet, we’re working closely with the agency to help create that regulatory roadmap — and in that, we see a real advantage, as we’re helping set the standard for those who follow.

Last year, when the FDA approved RYONCIL, the first off-the-shelf stem cell therapy for humans in the U.S., it marked a huge moment not just for human health, but for regenerative medicine as a whole. It validated years of work and opened the door for other cell-based therapies to follow.

At Gallant, our first veterinary stem cell therapy is currently under FDA review for conditional approval in 2026. It’s a major step forward, not just for us, but for the entire field.

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Gallant’s core innovation is developing off-the-shelf, FDA-approved stem cell therapies for pets. What were some of the early scientific or operational challenges you faced in making this model viable at scale?

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When we started developing our off-the-shelf therapy, we were essentially starting from scratch. Most of the existing expertise in veterinary stem cell work focused on fat-derived cells, but our approach uses mesenchymal stem cells from the uterus, which hadn’t been optimized in this way before. So the first challenge was simply figuring out how to isolate and grow those cells effectively. While some foundational studies existed, we had to translate that research into a repeatable, scalable process in the real world.

From there, we had to solve for growth — how do we expand these unique cells in a way that preserves their potency and quality? We developed a proprietary media formulation that allows us to produce up to 30 million doses from a single uterus.

That level of yield is virtually unheard of with any other stem cell source or technology.

Another key factor was building out our own GMP-compliant manufacturing facility early on. That’s almost unheard of for startups at this stage, but it was critical for us to ensure full control over quality and scalability, protection of trade secrets, and efficiency through the regulatory process. It’s a key differentiator for us.

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In Season 11, Episode 8 of Shark Tank, Aaron Hirschhorn secured $500,000 from Lori Greiner and Anne Wojcicki, and before that, raised $10 million. How much has Gallant raised since, and how much did appearing on Shark Tank help raise awareness for the brand?

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Gallant has raised a total of $40 million. Appearing on Shark Tank was an important early moment for the company, not just for visibility, but for education. It introduced millions of pet parents to the idea that stem cell therapy was even possible for animals. And every time the episode re-airs, we still see a flood of inquiries.

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Can you walk us through the business model that Gallant is currently pursuing?

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In short, we want to bring regenerative medicine to everyday veterinary care.

We develop off-the-shelf stem cell therapies designed to be available when pets need them – without the wait, the harvesting, or the complexity. We’re focused on diseases rooted in inflammation and immune dysfunction, including Feline Chronic Gingivostomatitis (FCGS), osteoarthritis in both dogs and cats, atopic dermatitis, and chronic kidney disease in cats. These are areas where conventional treatments often just manage symptoms. Our goal is to offer something more: therapies that actually help the body reclaim itself.

What makes this model possible is how we source and scale our cells. We use mesenchymal stem cells from uterine tissue collected during routine spay procedures of an FDA-qualified donor — tissue that would otherwise be discarded. From just one donor uterus, we can create up to 30 million doses.

Those cells are frozen and stored for use, giving veterinarians access to high-quality regenerative therapies without the complexity of harvesting tissue themselves. With FDA approval, they’ll also have the assurance of safety and efficacy — something that hasn’t been possible until now.

We manufacture our products in our own GMP-compliant facility in San Diego, which means we control the quality from start to finish. Today, we have tissue from six FDA-qualified feline donors stored in our freezers, which means we have the potential to produce 180 million doses. That’s enough to build a sustainable platform for targeting multiple conditions, at scale, for years to come.

The vision is that one day, every veterinary clinic will have a freezer stocked with regenerative therapies, readily available and easy to use, much like vaccines are today. That’s the future we’re working toward.

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What do you think most biotech entrepreneurs underestimate when they first decide to enter the pet industry?

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Many biotech entrepreneurs, and I was one of them, underestimate just how much rigor, forethought, and capital it takes to move an idea from the bench to a real product in veterinary medicine.

You need three things to succeed in biotech: talent, technology, and capital — and any one of those can break a company. Even with great science and funding, if you don’t have a team that can execute, it’s going to be very hard to get to the finish line.

I also think having a clear understanding of the problem and how your solution solves it is important. It’s easy to get caught up in how cool something is, but at the end of the day, the real question is: does it solve a meaningful problem?

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Some founders talk about a “crucible moment” — a major setback that either almost killed the company or changed its trajectory. What was that moment for Gallant, and what did you learn from it?

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Our ‘crucible moment’ came when a major funding deal collapsed at the last possible moment, taking other committed capital with it. And just like that, we went from almost closing our financing to starting over with a very short runway. We put everything on hold, all of our R&D, clinical trials, and manufacturing. It was a brutal moment, one in which I shed a few tears.

But it turned out to be one of the best things that ever happened to the company.

We tightened our belts, took pay cuts, and used the last of our available funds to focus inward. With everything else paused, our CTO urged me to let her have just a few thousand dollars to take this time and optimize our cell culture media — a nutrient-rich solution that provides the environment our stem cells need to survive, divide, and thrive. She made a number of nutrient cocktails and tested our cells in each of them to see which ones allowed them to grow, stay healthy, and improve their potency.

And — we arrived at a breakthrough. Instead of generating just a few million doses from a single uterus, her proprietary formulation enabled us to produce more than 30 million stable and potent doses.

It fundamentally changed the scalability and cost-efficiency of our product — something that might never have happened if we’d had the capital and had never slowed down to do this optimization work. It’s a clear example of the Marcus Aurelius quote paraphrased as “the obstacle is the way.”

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