Quince Therapeutics, Inc. (QNCX) Earnings Call Transcript & Summary

Hello, everyone. This is Dirk Thye, and I'm the CEO and the Chief Medical Officer of Quince Therapeutics. I'm here today to announce some exciting news. We have initiated the enrollment of our Phase III clinical trial for the treatment of ataxia-telangiectasia. That trial is called the NEAT trial, N-E-A-T, and it means studying the neurological effects of EryDex in ataxia-telangiectasia. Let me remind you what we're studying, what is ataxia-telangiectasia and why we're studying it. It's a rare autosomal recessive neurological pediatric genetic disease. It's caused by mutations in a gene called the ATM gene. The ATM gene is a really critical protein that manages a lot of different cellular functions in your body including DNA double-stranded repair. So mutations in this gene lead to a very bad phenotypic outcome. Children with this disease at a young age, typically around the age of 5, between the ages of 5 and 10, they experience really rapid neurological deterioration to the point that usually by the time they're 10 years old, they end up in a wheelchair. And then in later years, in their teenage years and beyond, they start experiencing repeated infections and then cancers. Typically, the life span for this disease is only in the mid-20s. So this is a terrible devastating disease. And importantly, there aren't any therapies approved for this disease. That's one of the reasons why we're very interested in studying the disease and one of the primary reasons we're developing EryDex as a therapy for AT. Now with respect to the Phase III clinical trial that we're performing that just initiated enrollment, the NEAT trial, it's performed under what's called a special protocol assessment agreement with the FDA. And the SPA specifies that if you have this agreement in place with the FDA, which we now do, if your Phase III study is successful, it can, as a single pivotal trial form the basis of an application in NDA with the FDA for approval of this indication in our case, the therapy of AT. There are 86 patients enrolled in this trial in a 1:1 randomization, placebo versus EryDex. The treatment period is 6 months long. It's a monthly treatment. So you get 6 monthly treatments over that period of time. The primary endpoint is called the RmICARS. This is a neurological scoring system that measures the amount of neurological deterioration and you can use this score to measure the progression of neurological problems over time. So you compare baseline to 6 months in actively treated patients versus that same change in placebo, and you're looking for a statistically significant improvement or delay in progression in the patients treated with EryDex versus placebo. It will take us about a year to enroll this study. So we anticipate getting data from this Phase III pivotal trial toward the end of 2025. In the meantime, we'll be actively working to enroll the study and perform it to the best of our ability. And you can follow our progress on our website or in any of our social media postings in the meantime. So thanks very much for your attention, and we'll see you next time.