Welcome to First 90 Days, a series dedicated to examining how pharma executives and other leaders are planning for success in their new roles. Today, we’re speaking to Arun Swaminathan, CEO of Coya Therapeutics, a biotech developing drug candidates for neurodegenerative diseases.
Since Arun Swaminathan took over the helm as CEO of Coya Therapeutics late last year, the Houston-based biotech has been on solid financial ground. With a recent $10 million private placement investment, Coya is positioned with a cash runway to last through 2026. Plus, a commercialization partnership established in 2023 with Dr. Reddy’s for its lead candidate in amyotrophic lateral sclerosis meant Coya had a path to market with less financial pressure — a happy feat for a dealmaker like Swaminathan.
With his background in Big Pharma and a decade of work in biotechs, Swaminathan also knows that Coya’s focus on neurodegenerative disease means swimming through choppy waters full of R&D shipwrecks. For ALS in particular, there are few options on the market, and the space was dealt a blow last year when Amylyx Pharmaceuticals’ Relyvrio, thought to be the first disease-modifying treatment for ALS, was pulled from the market. The drug gained FDA approval in 2022, but a confirmatory study failure was a death knell.
Despite the market setback, Swaminathan has leveraged his fiscal know-how to keep Coya sailing into the next clinical stages.
“You can’t control the waves, but you can learn to surf,” he said.
Coya aims to be a pioneer in ALS and the neuro space by enhancing regulatory T cells (Tregs) — white blood cells that regulate the immune system. By reducing inflammation, Coya believes it can slow ALS disease progression with its lead candidate, Coya-302.
The science can target a span of neurodegenerative diseases, and Coya has preclinical Treg-based investigational therapies for Alzheimer’s disease and Parkison’s in its pipeline, as well as a frontotemporal dementia candidate in IND-enabling testing.
"Our dream would be to be one of the companies that made some of these devastating neurodegenerative diseases livable diseases, where patients can lead a normal life."
Arun Swaminathan
CEO, Coya Therapeutics
Coya-302, is entering a phase 2b trial “sometime in 2025,” Swaminathan said.
“2026 is when we anticipate the top line from the phase 2 ALS [study], which will be a significant readout,” Swaminathan said.
And the next two years will be critical overall, with more data expected for its earlier stage candidates in frontotemporal dementia, Alzheimer’s disease and Parkinson’s.
Here, Swaminathan explains how he plans to employ lessons he’s learned to take Coya into the next stages and beyond as it looks to differentiate itself in the ALS market.
This interview has been edited for brevity and style.
PHARMAVOICE: Given your background in Big Pharma and as a biotech entrepreneur, what lessons from your experiences are you bringing to the table at Coya?
ARUN SWAMINATHAN: I like to say I grew up at Bristol Myers Squibb. BMS was an excellent teacher. What I fundamentally learned at BMS [was] being able to do a lot of different roles. I started as a clinical pharmacologist designing clinical studies. I was involved [in] … the whole drug development … from IND to an NDA filing on a product, and so that gave me a strong foundation of how our industry advances drugs. And then I transitioned more to the commercial side at BMS. It's a completely different perspective — how do I take good science and translate it into something meaningful for patients, and translate it into something of commercial value as well? Then I was involved in doing deals and business development. All of those experiences have prepared me to be a better leader when I transitioned to these smaller companies and to bring a lot of impact.
What these smaller companies teach you is something that bigger companies can't, which is how to be nimble, how to be cost effective, how to get the same things done without spending 10 times the money and how to be more efficient. With small companies, we can't afford too many experiments. We have to have a plan, stick with it, and we have to execute. And how do I convince investors? That's something I never had to do at a company like BMS. How do I convince people to understand our story and to become a better storyteller? Small companies taught me how to do all of that better, but most importantly, how to be fiscally responsible.
The neurodegenerative disease space is tough, with a lot of recent failures in both ALS and Alzheimer’s disease. What sets Coya apart in the neurodegenerative space?
We focus by fundamentally addressing neuro inflammation, [which] we believe is the trigger of all these diseases. If we work upstream by keeping regulatory T cell numbers up and functional, [we] can address neuro inflammation and all the cascading events that happen from there, including inflammation that eventually leads to nerve cell death and the miscommunication between them, which is what causes most of these neurodegenerative diseases. The differentiating thing about our approach is we're not hitting one downstream target, which sometimes works, sometimes doesn't. These are complex diseases where you have to hit the cascade. You have to be able to address multiple targets.
We also take an approach of combination therapies. We understand that one size may not fit all in these kinds of complex diseases. We have combined with CTLA4, [in ALS] for example, with our low-dose interleukin-2 to balance the two. CTLA4 works on a different aspect of the immune system, but together they keep the thyroid functions durable longer and also higher. We're looking for those types of synergies and combinations, because we believe that your neurodegenerative diseases have to be addressed through combination therapies.
What are the key market drivers for your drug candidates?
With ALS there [are] really no options. There [are] a couple of products on the market, but the ALS space still continues to progress, so the unmet need is really high. The market is waiting for a product. The commercial potential is pretty good for ALS. There are about 30,000 ALS patients in the U.S., 6,000 newly diagnosed [each year]. There's also room, I believe, for multiple players in ALS, because really, nobody is there, and we're hoping we can be among that first wave of ALS products that get to patients.
It’s a very concentrated market, as in, the number of physicians that are responsible for managing ALS patients is a pretty defined universe. It doesn't require a massive sales force. I'm talking low double digit numbers may be sufficient to get to these markets, so your commercial spend is not exorbitant. We've also partnered with Dr. Reddy's on the commercial side. They will commercialize the product for us. I think the ALS community is such an engaged patient community that they're acutely aware of all the drugs and development, and commercialization should be a pretty focused effort on Dr. Reddy's part with our support.
You’ve become known as a dealmaker in biotech. Coya raised $10 million in October through a private placement before you were CEO. How do you plan to ensure investor confidence as the pipeline progresses?
We're fortunate with our investors in the sense that we have had investors that have stayed with our story through multiple public rounds, even investors that are part of our IPO. They strongly believe in our scientific story. We have the right blend of pursuing targets that are not too esoteric, while being very innovative with strong intellectual property. And we're obviously in constant conversations with other potential partners to see if there's additional non-relative money, either through partnerships or grant money to continue to strengthen our cash position and extend our runway as well, without a need to go back to investors anytime soon.
What would you say is the biggest challenge for you as a new CEO?
It’s what probably most CEOs have in small biotechs — to keep us focused, keep us advancing towards our primary objectives, keep the company well funded, and make sure that we have the resources needed to get the job done. I'm fortunate that we are in that position at Coya, and my job as CEO is to continue to drive our vision and make sure that we have all the support we need to get there. Our dream would be to be one of the companies that made some of these devastating neurodegenerative diseases livable diseases, where patients can lead a normal life.
