Quince Therapeutics, Inc. is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology to deliver innovative therapies to those living with rare diseases. The company's proprietary AIDE technology platform is an innovative drug/device combination platform that uses an automated process to encapsulate a drug into a patient's own red blood cells.
Technology Platform
Red blood cells have several characteristics that make them a potentially ideal vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince's AIDE technology is designed to harness these benefits to allow for new and improved therapeutic options for patients living with high unmet medical needs.
The AIDE technology platform may confer benefits over conventional therapies and if so, AIDE has the potential to be applied to a broad range of small or large molecule drugs and biologics. EryDex, the company's lead asset, leverages the AIDE technology to encapsulate dexamethasone sodium phosphate (DSP) into a patient's own red blood cells, and is targeted to treat a rare pediatric neurodegenerative disease called Ataxia-Telangiectasia (A-T).
Market Opportunity
Quince completed an initial patient sizing project which confirmed that there are approximately 3,400 diagnosed patients with A-T in the U.S., aligning with an estimated U.S. prevalence of approximately 5,000 patients with A-T. Currently, there are no approved treatments for A-T and the global market, based on the company's internal estimates and assumptions, represents a more than $1 billion peak commercial opportunity. The company believes this could make EryDex an ideal lead asset to demonstrate the clinical and commercial potential of its AIDE technology.
Recent Developments
Quince expects to begin enrollment in the Phase 3 NEAT clinical trial of EryDex in A-T in the second quarter of 2024. The NEAT protocol is the subject of a Special Protocol Assessment (SPA) agreement with the FDA, which should allow for the submission of a New Drug Application (NDA) following completion of this study, provided the company obtains positive results. The company plans to submit the NDA in 2026 with expectations to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) shortly thereafter.
EryDex has been granted orphan drug designation for the treatment of A-T from both the U.S. FDA and EU EC. The EryDex System's components, including the Red Cell Loader (RCL) and EryKit, are CE marked medical devices in accordance with the Medical Devices Regulation (MDR) and Medical Devices Directive (MDD), respectively.
In the previous Phase 3 ATTeST trial, EryDex missed the primary efficacy endpoint, but saw statistically significant results in the age group of six to nine years old. Quince expects to initiate the NEAT study in this population in the second quarter of 2024 and announce the results in the second half of 2025.
Financials
The company's financial performance has been impacted by its ongoing research and development efforts. For the year ended December 31, 2023, Quince reported a net loss of $31.4 million, with no revenue generated. The company's annual operating cash flow and free cash flow for the same period were negative $18.3 million and negative $18.5 million, respectively.
For the first quarter of 2024, the company reported a net loss of $11.1 million, with no revenue generated. Quince's quarterly operating cash flow and free cash flow for the first quarter of 2024 were negative $8.4 million and negative $8.4 million, respectively.
Liquidity
As of March 31, 2024, Quince had $67.8 million in cash, cash equivalents, and short-term investments, which the company believes will be sufficient to fund its planned operations, including anticipated clinical and development activities related to EryDex, through completion of the Phase 3 NEAT clinical trial, and into 2026.
Outlook
The company's strategic priority is to complete the Phase 3 NEAT clinical trial of EryDex and investigate additional indications for the drug candidate. Quince also intends to pursue potential strategic partnerships to out-license ex-U.S. regional territories to extend its operational runway and further advance other potential indications.
Risks and Challenges
Risks associated with Quince's business include the successful integration of the EryDel acquisition, the ability to complete the Phase 3 NEAT trial and obtain regulatory approval for EryDex, the small target patient population for A-T, and the company's limited operating history as a newly acquired business. Additionally, Quince may require substantial additional funding to finance its operations and develop and evaluate current and future drug candidates.
Conclusion
Overall, Quince Therapeutics is a late-stage biotechnology company focused on advancing its proprietary AIDE technology platform to deliver innovative therapies for rare diseases. The company's lead asset, EryDex, represents a promising opportunity in the treatment of Ataxia-Telangiectasia, a rare and debilitating pediatric neurodegenerative disease. As Quince progresses through the Phase 3 NEAT trial and explores additional indications for its technology, investors will closely monitor the company's ability to execute on its strategic priorities and navigate the regulatory landscape.