Quince Therapeutics, Inc. - QNCX STOCK NEWS

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

Quince Therapeutics (Nasdaq: QNCX) has dosed the first patient in a Phase 3 clinical trial for its EryDex treatment, targeting Ataxia-Telangiectasia (A-T), a rare pediatric disease with no approved therapies.

This pivotal trial, under a Special Protocol Assessment with the FDA, will enroll about 106 patients aged six and older. Participants will undergo randomized, double-blind, placebo-controlled treatments over six infusions.

The primary efficacy endpoint is the change in scores on the modified International Cooperative Ataxia Rating Scale (RmICARS). Topline results are expected in the second half of 2025, with a planned New Drug Application (NDA) submission in 2026, assuming positive outcomes.

Quince completed a $5 million milestone payment to former EryDel shareholders upon dosing the first patient, with no further development-related payments owed.

Quince Therapeutics (Nasdaq: QNCX) has received Fast Track designation from the U.S. FDA for its EryDex System, intended for the treatment of Ataxia-Telangiectasia (A-T), a rare pediatric disease. The EryDex System uses Quince's proprietary AIDE technology to encapsulate dexamethasone sodium phosphate (DSP) in a patient’s red blood cells, aiming to mitigate the side effects of chronic corticosteroid treatments. Fast Track status highlights the severe unmet medical need for A-T, which affects roughly 10,000 patients in the U.S., U.K., and EU4 countries. A prior Phase 3 study of EryDex demonstrated encouraging efficacy and safety results. Quince is currently enrolling participants for its pivotal Phase 3 NEAT clinical trial under a Special Protocol Assessment (SPA) agreement with the FDA.

Quince Therapeutics, a late-stage biotech company, provided updates on its development pipeline and financial results for Q1 2024. The company is focusing on advancing their lead asset, EryDex, for ataxia-telangiectasia and Duchenne muscular dystrophy. They secured regulatory approvals for their pivotal Phase 3 NEAT clinical trial and are on track for enrollment. The potential market opportunity for their A-T treatment is estimated at over $1 billion globally. Quince is also evaluating other indications for EryDex and exploring strategic partnerships to support their pipeline expansion. Financially, they reported cash reserves of $67.8 million for Q1 2024 and expect to fund operations through 2026.

Quince Therapeutics, Inc. (Nasdaq: QNCX) will present at The Citizens JMP Life Sciences Conference to discuss their innovative drug delivery technology for rare diseases. The presentation by Quince's CEO and CMO will be available via live webcast on May 13, 2024.

Quince Therapeutics, Inc. (QNCX) provides an update on its development pipeline and financial results for the fourth quarter and fiscal year ended December 31, 2023. With the acquisition of EryDel S.p.A., the company focuses on Phase 3 development for EryDex to treat Ataxia-Telangiectasia. They have $75.1 million in cash to complete Phase 3 trials and expand into new indications. The NEAT clinical trial for A-T patients is progressing towards enrollment with potential NDA submission in 2026. Quince aims to redefine chronic corticosteroid therapy and explore new applications for its AIDE technology platform.

Quince Therapeutics, Inc. (QNCX) forms a Scientific Advisory Board with renowned experts to advance its Phase 3 asset, EryDex, for rare neurodegenerative disease treatment. The SAB includes experts in biochemistry, neurology, immunology, and hematology to support pipeline expansion and innovative drug delivery technology.