Quince Therapeutics Updates on Business and Q1 2024 Financials

Quince Therapeutics, Inc. (Nasdaq: QNCX), a biotechnology company focused on developing advanced drug delivery technologies for rare diseases, recently shared updates on its development pipeline and announced its financial results for the first quarter ending March 31, 2024. Dirk Thye, M.D., the CEO and Chief Medical Officer of Quince, emphasized the company's commitment to progressing its leading asset, EryDex, aimed at treating ataxia-telangiectasia (A-T). The company plans to begin enrolling patients for its pivotal Phase 3 study in the second quarter of 2024, with study sites in the U.S. and Europe.

Quince has also decided to pursue a second development program for EryDex targeting Duchenne muscular dystrophy (DMD). The rationale behind this decision stems from the potential of EryDex to offer the benefits of corticosteroids without the associated chronic toxicity that typically results from adrenal suppression. This new direction has gained support from both physicians treating DMD and advocacy groups, making it a promising development for the company.

The Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T) clinical trial has already secured regulatory approvals in the U.S. and the European Union. The international, multi-center study is designed to evaluate the neurological impact of EryDex in A-T patients. Approximately 106 patients will be enrolled, with the primary group consisting of those aged six to nine. The study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA, ensuring stringent regulatory oversight. Participants will receive six infusions of either EryDex or a placebo over the course of the study, with efficacy measured by changes in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS). Completion of the treatment period allows participants to join an open-label extension study. Quince aims to report topline Phase 3 NEAT results in the latter half of 2025, with a potential New Drug Application (NDA) submission in 2026, contingent on positive results.

The company has completed an initial patient sizing project, confirming approximately 3,400 diagnosed A-T patients in the U.S., aligning with an estimated U.S. prevalence of about 5,000 A-T patients. This represents a significant commercial opportunity, with a potential market exceeding $1 billion globally.

Apart from A-T, Quince is exploring additional indications for EryDex, particularly focusing on DMD where corticosteroids are the current standard but have limitations due to their toxicity. The company is leveraging its AIDE technology, which encapsulates corticosteroids in a patient's own red blood cells, to potentially provide a safer and effective treatment option. Quince is also investigating other diseases where chronic corticosteroid treatment poses safety concerns, including various ataxias, neuromuscular conditions, hematology, cancer, and autoimmune diseases.

Quince plans to explore strategic partnerships to out-license ex-U.S. rights, thereby extending its operational runway and supporting potential NDA approval for EryDex in the U.S. The company continues to advance its drug development pipeline, focusing on rare and debilitating diseases.

Financially, Quince reported cash, cash equivalents, and short-term investments of $67.8 million as of March 31, 2024. This funding is expected to support the company's development plans through 2026. The company reported research and development expenses of $3.7 million and general and administrative expenses of $5.0 million for the first quarter of 2024. The net loss for the quarter was $11.1 million, with net cash usage in operating activities at $8.4 million.

In summary, Quince Therapeutics is making significant strides in advancing its lead asset, EryDex, for the treatment of A-T and DMD. With robust financial health and strategic planning, the company is well-positioned to continue its development efforts and potentially provide effective treatments for rare diseases.