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Quince Therapeutics, Inc. (NASDAQ: QNCX) is a preclinical stage biopharmaceutical company committed to advancing innovative precision therapeutics for treating debilitating and rare diseases. Quince's research and development efforts have led to the discovery of a unique bone-targeting drug platform designed to deliver small molecules, peptides, or large molecules directly to the site of bone fractures and diseases. This targeted approach aims to promote rapid healing while minimizing off-target safety concerns compared to traditional, non-targeted therapeutics.
In addition to its bone-targeting platform, Quince Therapeutics is actively developing therapeutics based on novel theories of the causes of Alzheimer's and other degenerative disorders. The company's research has pinpointed a specific, undisclosed pathogen associated with neurodegeneration and beta amyloid production. Validated in numerous animal models, Quince is advancing a proprietary small molecule towards human clinical testing, positioning itself at the forefront of groundbreaking medical science.
One of the latest updates from Quince Therapeutics includes a revised acquisition proposal from Echo Lake Capital, offering to purchase all outstanding shares of common stock at $1.80 per share in cash. Additionally, this offer includes a contingent value right (CVR) to receive 85% of the future net proceeds from the Lighthouse Pharmaceuticals transaction announced on January 27, 2023. This proposal represents a significant premium over the company's recent stock price and underscores the potential value of Quince's innovative drug assets.
Quince Therapeutics boasts a strong financial position with approximately $2.30 per share of net cash and investments, no active drug marketing or development expenditures, and potential future earnings from the Lighthouse Pharmaceuticals asset sale. As the company continues to develop its pipeline and explore strategic partnerships, it remains a compelling entity in the biopharmaceutical landscape.
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.
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.