Meet Alterity Therapeutics: Fly exclusive interview with CEO David Stamler

In an exclusive interview, Alterity Therapeutics’ (ATHE) CEO David Stamler met with The Fly to discuss the company, the biotech industry, ongoing trials, upcoming milestones and much more.

NEURODEGENERATIVE DISEASES: Alterity Therapeutics is a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases. The company believes its lead asset, ATH434, has the potential to treat various forms of Parkinsonian disorders. Alterity also has a broad drug discovery platform generating patentable chemical to intercede in disease processes.

“We’re an Australian-based biotech company that’s trying to establish ourselves in the U.S. We’ve been around for about 20 to 25 years, and we have a longstanding interest in treating neurologic diseases, in particular neuro-diseases with neurodegeneration. We have been advancing our lead asset for a better part of 8 years, and have generated some really exciting data that gives hope to people who have a very bad disease,” CEO David Stamler explained to The Fly.

MULTIPLE SYSTEM ATROPHY: The company has recently completed two Phase 2 trials in Multiple System Atrophy MSA – Early Stage and Advanced. “One completed in the 1st quarter of this year. And that was in the study in early-stage patients. We had a well-controlled study, with two active dose groups and a placebo group, and we demonstrated something that’s never been shown before in this disease, which is that the drug had a clinically meaningful effect on slowing the progression of the disease. So that was probably the most exciting thing to come out of the company in several years.

“And then in the summer, we generated data from our open label study, which was in advanced MSA patients. And in that study, we showed that patients who were further along in their disease progression had a similar treatment benefit as compared to those in the early-stage trials. So that was also very encouraging because it’s difficult to diagnose this disease. The other thing I would say from both studies — and I’m just very overarching view — is that the drug was quite safe,” the executive said.

PARKINSON’S DISEASE: Discussing other potential applications for its lead drug and expansion of the company’s pipeline, Alterity’s CEO highlighted the interest in treating Parkinson’s disease. “Our lead candidate is being developed for the treatment of Multiple System Atrophy. Patients have Parkinson’s disease symptoms, but also other symptoms that causes much or more morbidity. We initially are most interested in Parkinson’s disease. There is some overlap in terms of the pathology and in terms of how the drug works. As a small company, we decided to take on MSA first, because there’s an urgent need in these patients, who have nothing to treat their underlying disease. And it’s a very bad disease. It progresses rapidly. But we’ve never lost sight of our interest in Parkinson’s disease, where we generated a lot of data. We are very likely to take the molecule forward in Parkinson’s disease down the road,” Stamler tells The Fly.

FDA MEETINGS: Looking over the remainder of the year and early 2026, the executive points out Alterity is planning a Phase 3 study of Alterity’s ATH434. “We are actively planning that Phase 3 study. And a critical aspect of that planning is to meet with the FDA. We’re planning a series of meetings with the FDA. We are very focused on getting some of those FDA meetings on the books. After those are under our belt, the goal would be to then organize the end of Phase 2 meeting, which is the critical meeting, to reach agreement on the study design for phase three. We think that’s going to happen mid-year.”

MISCONCEPTIONS: Discussing any potential misconceptions about the company, Alterity’s CFO tells The Fly that he believes “sometimes with biotech and pharmaceuticals, Wall Street gets focused on one aspect of the company and kind of like just funnels everything through that lens. Right now, there’s maybe a lack of conception or a lack of consideration of Alterity because we are small and because we are technically headquartered in Australia. When I joined the company 8 years ago, it was really to try and put a U.S. face on the company, and to bring my development experience and success to the company. I would say we are really emerging as a U.S. company, and people should take notice.

“The other thing that people often think about when they think about the diseases that we’re targeting, is that treating neurodegeneration is difficult or impossible. It’s very, very complicated. So many of these diseases are difficult to treat. But I think our data speaks otherwise, and I think that’s why I’m so excited to be where I am and to be where this company is, because we are really targeting this disease in a way that no one else is doing. I think we’ve shown, with our data, that we’re at a huge value inflection point, in terms of getting people’s attention for the company, for treating neurodegeneration.”

“Meet the Company” is The Fly’s recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.