Quince Therapeutics Announces Publication of Use of eDSP in Early-Stage Clinical Studies in Pulmonary and Inflammatory Bowel Disorders

Quince Therapeutics, Inc. (NASDAQ:QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, announced the publication of a summary of early-stage clinical studies of its Phase 3 lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in a patient's own red blood cells), in pulmonary and inflammatory bowel disorders (IBD) in the scientific journal Frontiers in Drug Delivery.

Dirk Thye, M.D., Quince's Chief Executive Officer and Chief Medical Officer, said, "This new Frontiers in Drug Delivery publication highlights the potential for clinical utility of our lead asset, eDSP, across pulmonary and IBD indications. The purpose of these prior studies was to demonstrate that eDSP can be delivered at efficacious doses while avoiding the frequent and debilitating common toxicities associated with chronic corticosteroid therapy. Importantly, it also speaks to the potential of eDSP to transform treatment paradigms across multiple diseases where chronic corticosteroid treatment is – or has the potential to become – the standard of care. As we rapidly approach topline results in the middle of the first quarter of 2026 for our Phase 3 NEAT study of eDSP in Ataxia-Telangiectasia (A-T), we believe these data further underscore not only the ability of eDSP to deliver corticosteroid efficacy without toxicities, but also highlight the significant pipeline expansion opportunities that lie ahead of Quince, assuming positive NEAT results."

Frontiers in Drug Delivery Publication Highlights

The Frontiers in Drug Delivery publication entitled Use of Encapsulated Dexamethasone Sodium Phosphate (eDSP) in Chronic Obstructive Pulmonary Disease, Cystic Fibrosis, and Inflammatory Bowel Disorders summarizes early-stage studies of eDSP conducted across eight clinical trials in patients with pulmonary and IBD.

Highlights include:

• Broad application of eDSP across multiple disease indications: Early-stage clinical studies investigated eDSP in patients, whose age ranged from five to 83 years, with chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), Crohn's disease (CD), and ulcerative colitis (UC). DSP was loaded into autologous erythrocytes ex vivo and reinfused every two weeks or monthly with follow-ups that ranged from one to 24 months.
• Encouraging results in pulmonary and IBD: eDSP resulted in improved FEV1 and reduced infections in CF patients and improved symptoms in COPD with markedly reduced corticosteroid doses. In IBD, eDSP at low doses enabled corticosteroid withdrawal in 60% to 78% of patients and achieved remission in pediatric and adult CD and UC. Importantly, adverse toxicity effects typical of corticosteroids were notably absent while pharmacokinetic studies documented persistence of DSP levels up to 28 days post-infusion. Notably, the mean dose used in these early trials did not exceed 10 mg of eDSP per infusion suggesting that glucocorticoid receptor occupation could be achieved with a low eDSP dose.
• eDSP feasibility and tolerability across wide age range: Early studies demonstrate that eDSP is a feasible and well-tolerated treatment in children and older patients, delivering low-dose corticosteroids with prolonged therapeutic levels. These findings support further development of erythrocyte-based drug delivery for chronic inflammatory diseases in patients with corticosteroid-sensitive or corticosteroid-dependent disease.

About eDSP

eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient's own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment.

eDSP leverages Quince's proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient's own red blood cells. Red blood cells have several characteristics that make them a potentially effective 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 the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response.

Currently, Quince is advancing its pivotal Phase 3 NEAT (Neurological Effects of eDSP in Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial of eDSP in patients with Ataxia-Telangiectasia (A-T). a rare inherited autosomal recessive neurodegenerative and immunodeficiency disorder. The NEAT study is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of eDSP in patients with A-T. This study consists of two cohorts randomized (1:1) between eDSP or placebo and treatment includes six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo.

The company expects to report topline results from its Phase 3 NEAT clinical trial in the middle of the first quarter of 2026.

About Quince Therapeutics

Quince Therapeutics, Inc. (NASDAQ:QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube.

Forward-looking Statements

Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including expected timing and outcome of Phase 3 NEAT topline results; ; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), pulmonary and inflammatory bowel disorders, and other potential indications; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and potential benefits of eDSP and the company's market opportunity. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2025, Quarterly Report on Form 10-Q filed with the SEC on November 12, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.

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Media & Investor Contact:

Stacy Roughan

Quince Therapeutics, Inc.

Vice President, Corporate Communications & Investor Relations

[email protected]