SOUTH SAN FRANCISCO, CA – Quince Therapeutics, Inc. (NASDAQ: QNCX), a biotech company focused on rare diseases, recently presented safety data from its Phase 3 ATTeST study at the 53rd Annual Meeting of the Child Neurology Society. The study involved EryDex, an experimental treatment for ataxia telangiectasia (AT), a rare neurodegenerative disease.
The poster presentation highlighted that EryDex was generally well tolerated in the study, with most treatment-emergent adverse events (TEAEs) being mild to moderate. Importantly, side effects typically associated with chronic steroid use were not observed in the patients. The study reported that three patients discontinued treatment due to adverse events, and one serious adverse event was considered unlikely to be related to treatment.
Quince Therapeutics CEO Dirk Thye, MD, expressed optimism about EryDex’s potential, noting that its safety profile supports further evaluation of AT therapy. The company’s pivotal Phase 3 NEAT study is currently recruiting patients in the US and Europe, with peak results expected in late 2025.
The NEAT study aims to evaluate the neurological effects of EryDex in AT patients and will be conducted under a special protocol review with the FDA. Quince has also received EryDex’s Fast Track designation, indicating the potential to address an unmet medical need.
AT is a genetic disease that causes neurological degeneration and immunodeficiency, often rendering patients wheelchair-bound by adolescence. There are approximately 4,600 diagnosed cases in the US and an estimated 5,000 in the UK and EU4 countries, with no approved treatments available.
EryDex uses Quince’s proprietary AIDE technology, which encapsulates the drug in the patient’s own red blood cells, reducing the side effects of chronic corticosteroid use.
Quince Therapeutics is a late-stage biotechnology company focused on developing treatments for rare diseases. The information in this article is based on a press release.
In other recent news, Quince Therapeutics has received recognition from both Rodman & Renshaw and EF Hutton, who have initiated coverage of the company with a Buy rating. Analysts focused on the company’s innovative approach to treating the rare genetic disease Ataxia-Telangiectasia (AT) with its lead therapeutic candidate, EryDex. Quince Therapeutics has published promising data from its Phase 3 ATTeST clinical trial, which shows a favorable safety profile and benefit in some patients, particularly children aged 6-9 years. However, the company faces a possible exit from the Nasdaq Global Select Market because it does not meet the minimum bid price requirement. The deadline is December 17, 2024, when it must return to comply with the requirements. On a positive note, Quince’s EryDex system has been granted Fast Track status by the US Food and Drug Administration (FDA), marking a major regulatory milestone. These are some of the recent developments regarding Quince Therapeutics as the company continues to innovate and navigate regulatory challenges.
InvestingPro Insights
As Quince Therapeutics (NASDAQ: QNCX ) pursues its EryDex treatment for ataxia-telangiectasia, investors may find some new context from recent financial data and market developments useful.
According to InvestingPro data, Quince Therapeutics has a market cap of $71.84 million, reflecting its status as a small-cap biotechnology company. The stock has shown considerable momentum recently, with a price return of 144.96% over the past month and a return of 88.55% over the past year. This share price increase is in line with the positive safety data presented at the Child Neurology Society Annual Meeting and the ongoing Phase 3 NEAT trial.
However, it is important to note that Quince Therapeutics is currently not profitable, with an adjusted operating profit of -USD 29.52 million for Q2 2023 over the trailing twelve months. This is typical of early-stage biotech companies, as they invest heavily in research and clinical trials. trials before earning revenue from approved products.
InvestingPro Tips highlights that Quince has more cash than debt on its balance sheet, which could be crucial in funding ongoing clinical trials and operations. However, the company also quickly burns through its money, which is a common challenge for biotechnology companies developing new treatments.
Investors should be aware that while the stock is trading near its 52-week high, analysts do not expect the company to be profitable this year. This underscores the speculative nature of investing in early-stage biotech companies and the importance of EryDex’s success to Quince’s future prospects.
For those interested in deeper analysis, InvestingPro offers 14 additional tips for Quince Therapeutics that provide a more comprehensive picture of the company’s financial health and market position.
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