Quince Therapeutics, Inc. - QNCX STOCK NEWS

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.

Quince Therapeutics (Nasdaq: QNCX) presented safety data from its Phase 3 ATTeST clinical trial at the 53rd Child Neurology Society Annual Meeting. The trial evaluated EryDex (intra-erythrocyte dexamethasone sodium phosphate) in Ataxia-Telangiectasia (A-T) patients. Results showed EryDex was generally well-tolerated with mostly mild to moderate side effects. The company is currently conducting a pivotal Phase 3 NEAT trial, expecting to enroll 86 patients aged 6-9 years and 20 patients aged 10+ years. Topline results are expected in Q4 2025, with potential FDA and EMA submissions in 2026.

Quince Therapeutics (Nasdaq: QNCX), a late-stage biotechnology company focusing on rare diseases, has announced its participation in three upcoming investor conferences:

1. 2024 Maxim Healthcare Virtual Summit: CEO and CMO Dirk Thye, M.D., will participate in a fireside chat on October 17, 2024, at 3:00 p.m. ET.

2. LD Micro Main Event XVII: COO and CBO Brendan Hannah will present a company overview on October 29, 2024, at 6:30 p.m. ET.

3. ThinkEquity Conference 2024: President Charles Ryan, J.D., Ph.D., will present a company overview on October 30, 2024, at 3:00 p.m. ET.

Webcasts and registration details for these events are available on Quince's Investor Relations website.

Quince Therapeutics (Nasdaq: QNCX), a late-stage biotech company focusing on rare diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. Dr. Dirk Thye, the company's CEO and CMO, will present on September 9, 2024, at 7 a.m. Eastern Time.

This presentation marks an important opportunity for Quince to showcase its progress and potential to investors. The company's approach centers on harnessing a patient's own biology for treating rare diseases, a cutting-edge area in biotechnology. Interested parties can access a webcast of the presentation through Quince's Investor Relations website, providing transparency and accessibility to potential investors and stakeholders.

Quince Therapeutics (Nasdaq: QNCX) announced the publication of Phase 3 ATTeST clinical trial data in The Lancet Neurology, evaluating EryDex for treating Ataxia-Telangiectasia (A-T). The study, involving 175 participants across 22 institutions in 12 countries, demonstrated a favorable safety profile and positive effects in patients aged 6-9 years.

Key findings include:

• No serious safety concerns typically associated with chronic corticosteroid use
• Statistically significant reduction in neurological symptoms in 6-9 year olds receiving high-dose EryDex
• Potential treatment delays due to COVID-19 pandemic affected overall results

Quince has initiated the pivotal Phase 3 NEAT study under FDA Special Protocol Assessment, with topline results expected in Q4 2025.

Quince Therapeutics (QNCX) reported its Q2 2024 financial results and provided a business update. Key highlights include:

- Enrolled 7 patients in the pivotal Phase 3 NEAT clinical trial for Ataxia-Telangiectasia (A-T)

- Strong cash position of $59.4 million, expected to fund operations into 2026

- Phase 3 NEAT topline results expected in Q4 2025

- Potential NDA and MAA submissions in 2026, pending positive results

- Granted FDA Fast Track designation for EryDex in A-T treatment

- Updated U.S. A-T patient estimate to 4,600, representing a $1+ billion global market opportunity

- Reported Q2 2024 net loss of $27.7 million, or $0.64 per share

- R&D expenses of $4.2 million and G&A expenses of $4.7 million for Q2 2024