Quince Therapeutics Q2 2024 Financial Update and Business Report

Quince Therapeutics, Inc., a biotechnology company based in South San Francisco and listed on Nasdaq (QNCX), specializes in harnessing the patient’s own biology for treating rare diseases. The company recently updated its development pipeline and disclosed its financial results for the second quarter ending June 30, 2024.

During the second quarter of 2024, Quince achieved a significant milestone by enrolling the first patient in its pivotal Phase 3 NEAT clinical trial for Ataxia-Telangiectasia (A-T). This clinical study aims to evaluate the neurological effects of EryDex, a medication involving dexamethasone sodium phosphate encapsulated in autologous red blood cells, on patients with A-T. So far, seven patients have been enrolled across clinical sites in the U.S., U.K., and the European Union. The trial aims to enroll approximately 86 patients aged six to nine years and around 20 patients aged ten years or older. Participants will undergo six infusions of EryDex or placebo, scheduled between 21 to 30 days apart, with the primary endpoint being measured by changes in a modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo.

Quince expects to report the topline results of the Phase 3 NEAT trial in the fourth quarter of 2025. If the results are positive, the company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026. The trial is being conducted under a Special Protocol Assessment agreement with the FDA.

In addition to the NEAT trial, Quince has received Fast Track designation from the FDA for its EryDex System due to its potential to meet high unmet medical needs in A-T. The company also updated its estimates on the number of diagnosed A-T patients in the U.S. to approximately 4,600, an increase from the previous estimate of about 3,400. Currently, there are no approved treatments for A-T, making this a potential $1 billion market opportunity globally.

Quince is also generating proof-of-concept clinical trial designs to evaluate EryDex for treating Duchenne muscular dystrophy (DMD), including those intolerant to corticosteroids. The company plans to initiate a DMD study in 2025. Furthermore, Quince intends to participate in upcoming scientific congresses, including presenting EryDex safety data at the 53rd Child Neurology Society Annual Meeting in November 2024 and other presentations at the 2024 International Congress for Ataxia Research.

To support its pivotal Phase 3 NEAT study and strategic business partnerships, Quince has expanded its leadership team by adding Brent Roeck as Vice President of Program and Alliance Management and Katie George as Executive Director of Clinical Operations. Together, they bring over 50 years of experience in rare diseases and the biotech and pharmaceutical industries.

Quince is also exploring other potential indications for EryDex, focusing on areas where chronic corticosteroid treatment is standard but poses safety concerns. These areas include various ataxias, neuromuscular conditions, hematology, cancer, and autoimmune diseases. Additionally, the company is evaluating strategic partnerships to out-license ex-U.S. rights to extend its operational runway supporting the potential NDA approval of EryDex in the U.S.

Financially, Quince reported having $59.4 million in cash, cash equivalents, and short-term investments as of June 30, 2024. The company expects this cash position to fund its development plans through the Phase 3 NEAT topline results in 2025, including approximately $20 million for the NEAT trial and $15 million for an open label extension study. R&D expenses for the second quarter amounted to $4.2 million, primarily for start-up costs related to the Phase 3 NEAT trial. General and administrative expenses were $4.7 million. The net loss for the quarter was $27.7 million, significantly impacted by a $17.1 million non-cash goodwill impairment charge.

For the first half of 2024, Quince reported a net cash usage in operating activities of $17.1 million, reflecting a net loss of $38.9 million, adjusted by $24.0 million in non-cash items.

Quince Therapeutics remains committed to advancing its pipeline and exploring new treatment opportunities to address unmet needs in rare diseases.