Quince - QNCX STOCK NEWS

Quince Therapeutics (NASDAQ: QNCX) reported key progress in its Phase 3 NEAT clinical trial, which has exceeded 50% enrollment with 61 participants randomized. The trial evaluates eDSP for treating Ataxia-Telangiectasia (A-T), with topline results expected in Q4 2025.

The company reported financial results for FY2024:

• Cash position: $40.8 million, expected to fund operations through Phase 3 results into 2026
• R&D expenses: $18.6 million
• G&A expenses: $17.6 million
• Net loss: $56.8 million ($1.31 per share)

Notable developments include FDA Fast Track designation for eDSP, publication of trial results in The Lancet Neurology, and a U.S. patent extension to 2036. The company plans to initiate a Phase 2 trial for Duchenne muscular dystrophy in 2025.

Quince Therapeutics (NASDAQ: QNCX) announced significant progress in its Phase 3 NEAT clinical trial for Ataxia-Telangiectasia (A-T), with enrollment nearing 50%. The company has enrolled 46 participants to date, including 40 in the primary analysis population of six to nine-year-olds, with plans to enroll approximately 86 patients in this age group and 20 patients aged 10 or older.

The NEAT trial is being conducted under a Special Protocol Assessment agreement with the FDA, evaluating EryDex (dexamethasone sodium phosphate encapsulated in autologous red blood cells) for A-T treatment. The company expects to complete enrollment in Q2 2025 and report topline results in Q4 2025.

An open-label extension has been initiated with 17 participants enrolled across the U.S., U.K., and European Union. Pending positive results, Quince plans to submit a New Drug Application to the FDA and a Marketing Authorization Application to the EMA in 2026.

Quince Therapeutics (Nasdaq: QNCX), a late-stage biotechnology company focusing on rare disease treatments, has announced its upcoming participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's CEO and CMO, Dr. Dirk Thye, will engage in a fireside chat during this virtual event on Wednesday, February 12, 2025, at 2:00 p.m. Eastern Time.

Investors and interested parties can access the live webcast through the Events page in the News & Events section of Quince's Investor Relations website at ir.quincetx.com. A recording of the presentation will be made available shortly after the live event concludes.

Quince Therapeutics (NASDAQ: QNCX) has received a Notice of Allowance from the USPTO for a patent application covering their method of treating Ataxia-Telangiectasia (A-T) using the EryDex process. The patent, extending to 2036, covers the preparation of erythrocytes loaded with pharmaceutical substances.

The new patent application supplements existing U.S. Patent No. 10,849,858 and features broader claims than the parent patent. Once issued, the patent will be listable in the FDA's Orange Book, requiring generic applicants to certify against Quince's patent, providing notice of future generic applications and stay provisions under the Hatch-Waxman Act.

This protection complements the market exclusivity provided by Orphan Drug Designation in both the U.S. and Europe. The company plans to pursue similar claims with the European Patent Office.

Quince Therapeutics (Nasdaq: QNCX) has announced an upcoming investor webinar focused on Ataxia-Telangiectasia (A-T), scheduled for February 7, 2025, at 10:00 a.m. Eastern Time. The webinar will feature Dr. Mary Kay Koenig, a leading A-T expert and board-certified child neurologist, who will present on A-T natural history, current treatments, competitive landscape, and Quince's Phase 3 EryDex clinical trial.

Dr. Dirk Thye, Quince's CEO and CMO, will provide a corporate overview and update on the ongoing Phase 3 NEAT clinical trial enrollment. Dr. Koenig, currently serving as Professor and Associate Vice-Chair for Clinical Research at McGovern Medical School, brings extensive expertise in neurodegenerative disorders and holds multiple leadership positions, including Director at the Center for Treatment of Pediatric Neurodegenerative Disease.

Quince Therapeutics (NASDAQ: QNCX) announced the publication of safety data in Frontiers in Neurology regarding EryDex treatment in pediatric patients with Ataxia-Telangiectasia (A-T). The data comes from patients treated for a minimum of 24 months in Phase 3 clinical trials.

EryDex, which encapsulates dexamethasone sodium phosphate in patients' own red blood cells, demonstrated favorable safety profiles without the typical chronic side effects associated with standard corticosteroid treatment. The company has administered over 6,000 monthly doses to nearly 400 patients over 10+ years.

The most common treatment-related side effect was temporary infusion-related pruritus. The company is currently conducting the pivotal Phase 3 NEAT trial under a Special Protocol Assessment agreement with the FDA, with topline results expected in Q4 2025. Quince plans to submit New Drug Application to FDA and Marketing Authorization Application to EMA in 2026, pending positive results.

Quince Therapeutics (Nasdaq: QNCX) has appointed Dr. William Whitehouse to its Scientific Advisory Board (SAB). Dr. Whitehouse, an Honorary Clinical Associate Professor at the University of Nottingham and retired Consultant Paediatric Neurologist at Nottingham Children's Hospital, brings extensive expertise in rare pediatric neurodegenerative diseases, particularly Ataxia-Telangiectasia (A-T). He joins seven founding SAB members who are experts in various medical fields.

Dr. Mauro Magnani, Chair of Quince's SAB, highlighted Dr. Whitehouse's valuable contributions to advancing Quince's lead asset, EryDex, aimed at treating A-T. Dr. Whitehouse expressed enthusiasm for collaborating with Quince's team to support EryDex's development, which has the potential to be a first-to-market treatment for A-T.

Dr. Whitehouse has a distinguished academic and clinical background, with significant contributions to A-T research and care. His appointment is expected to bolster Quince's efforts in treating rare diseases, with a pivotal Phase 3 clinical trial for EryDex currently underway. Quince's SAB will also aid in expanding the company's pipeline to include other rare disease indications.

Quince Therapeutics (QNCX) reports progress in its Phase 3 NEAT clinical trial for Ataxia-Telangiectasia treatment, with 32 patients enrolled across U.S., U.K., and EU sites. The company aims to complete enrollment in Q2 2025 and report topline results in Q4 2025. Financial highlights include $47.8 million in cash and equivalents, R&D expenses of $4.9 million, and a net loss of $5.5 million ($0.13 per share) for Q3 2024. The company expects its cash runway to fund operations through Phase 3 NEAT results and into 2026, including $20 million for the NEAT trial and $15 million for an open-label extension study.

Quince Therapeutics (Nasdaq: QNCX) presented data from its Phase 3 ATTeST clinical trial at the 2024 International Congress for Ataxia Research. The trial evaluated EryDex for treating Ataxia-Telangiectasia (A-T). Key findings showed that 24-month EryDex treatment didn't adversely affect growth and bone mineral density in A-T patients, comparing favorably to natural disease progression. The study also identified that mICARS and RmICARS measures best reflect disease progression in A-T patients aged 6-10 years. Quince is currently conducting a pivotal Phase 3 NEAT trial under FDA Special Protocol Assessment, with topline results expected in Q4 2025.