Quince Therapeutics Provides Business Update and Reports Fiscal Year 2024 Financial Results

Phase 3 NEAT clinical trial exceeds 50% enrollment with new study site activations expected to accelerate screenings and randomization

Existing cash position of $40.8 million expected to provide operating runway through Phase 3 topline results into 2026

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--March 24, 2025-- 

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, today provided an update on the company's development pipeline and reported financial results for the fiscal year ended December 31, 2024.

Dirk Thye, M.D., Quince's Chief Executive Officer and Chief Medical Officer, said, "Our Phase 3 pivotal NEAT clinical trial has exceeded 50% enrollment with 71 participants screened and 61 randomized. Recent and upcoming new site activations are expected to accelerate enrollment through our target completion date in the second quarter of 2025. Assuming target enrollment completion, topline results from the NEAT study are anticipated in the fourth quarter of 2025."

Pivotal Phase 3 NEAT Clinical Trial

   -- Enrolled 61 participants to date in the company's Phase 3 NEAT 
      (Neurological Effects of eDSP on Subjects with A-T; 
      NCT06193200/IEDAT-04-2022) clinical trial to evaluate the neurological 
      effects of eDSP (previously referred to as EryDex) in patients with 
      Ataxia-Telangiectasia (A-T), including 54 participants in the six to nine 
      year-old primary analysis population. 
 
   -- Transitioned 24 participants to date to the NEAT open label extension 
      study (NCT06664853/IEDAT-04-2022). Participants who complete the full 
      treatment period, complete study assessments, and provide informed 
      consent are eligible to transition to an open label extension study. 
 
   -- Expect screening and randomization to accelerate in the coming weeks due 
      to several new geographic regions and sites scheduled for activation. 
 
   -- Quince plans to enroll approximately 86 patients with A-T ages six to 
      nine years old (primary analysis population) and approximately 20 
      patients with A-T ages 10 years or older. 
 
   -- Pivotal Phase 3 NEAT clinical trial is being conducted under a Special 
      Protocol Assessment agreement with the U.S. Food and Drug Administration 
      (FDA). 
 
   -- Expect to report Phase 3 NEAT topline results in the fourth quarter of 
      2025 with a New Drug Application (NDA) submission to the FDA and a 
      Marketing Authorization Application $(MAA)$ submission to the European 
      Medicines Agency (EMA) in 2026, assuming positive study results. 
 
   -- NEAT is an international, multicenter, randomized, double-blind, 
      placebo-controlled study to evaluate the neurological effects of the 
      company's lead asset, eDSP (dexamethasone sodium phosphate [DSP] 
      encapsulated in autologous red blood cells), in patients with A-T. 
 
   -- Participants will be randomized (1:1) between eDSP or placebo and 
      treatment will consist of six infusions scheduled once every 21 to 30 
      days. The primary efficacy endpoint will be measured by the change from 
      baseline to last visit completion in a rescored modified International 
      Cooperative Ataxia Rating Scale (RmICARS) compared to placebo as per the 
      SPA agreement with the FDA. 

Pipeline and Corporate Updates

   -- Generating Phase 2 clinical trial study designed to evaluate eDSP for the 
      potential treatment of patients with Duchenne muscular dystrophy (DMD). 
      Quince plans to initiate a DMD Phase 2 study in 2025, which the company 
      expects to conduct utilizing capital efficient study approaches and with 
      financial support from grant and/or opportunistic funding opportunities. 
 
   -- Published long-term safety data from patients with A-T treated with eDSP 
      for a minimum of 24 months in Frontiers in Neurology in January 2025. The 
      online publication titled Long-term safety of dexamethasone sodium 
      phosphate encapsulated in autologous erythrocytes in pediatric patients 
      with Ataxia-Telangiectasia can be accessed here. 
 
   -- Appointed Dr. William Whitehouse, Honorary Clinical Associate Professor 
      of the School of Medicine at the University of Nottingham and recently 
      retired Consultant Pediatric Neurologist at Nottingham Children's 
      Hospital, Nottingham University Hospitals NHS Trust, to the company's 
      Scientific Advisory Board (SAB). 
 
   -- Strengthened Quince's growing intellectual property portfolio and 
      long-term market position with the issuance of a Notice of Allowance from 
      the U.S. Patent and Trademark Office's (USPTO) in February 2025. This 
      extends the company's patent claims into 2036 in the U.S., supplementing 
      its existing U.S. patent with coverage of patent claims related to method 
      of treating patients with A-T using Quince's proprietary process to 
      encapsulate DSP in autologous red blood cells. 
 
   -- Held an investor webinar in February 2025 featuring key opinion leader 
      $(KOL)$ Dr. Mary Kay Koenig from UTHealth Houston with a discussion focused 
      on addressing the high unmet need in A-T. During the investor webinar, 
      Dr. Koenig 1) provided an A-T natural history overview, 2) detailed 
      current symptomatic treatment approaches for patients with A-T, 3) 
      discussed the competitive therapeutic A-T landscape, and 4) provided an 
      overview of Quince's Phase 3 NEAT clinical trial of eDSP for the 
      treatment of A-T. A replay of the A-T KOL investor webinar is available 
      here. 

Fiscal Year 2024 Operating Highlights

   -- Granted Fast Track designation from the FDA for Quince's eDSP System for 
      the treatment of patients with A-T in June 2024. 
 
   -- Published efficacy and safety results from the company's Phase 3 ATTeST 
      clinical trial evaluating eDSP for the treatment of A-T in medical 
      journal The Lancet Neurology. 
 
   -- Participated at notable scientific meetings, including poster 
      presentations at the 53rd Child Neurology Society $(CNS)$ Annual Meeting 
      and the 2024 International Congress for Ataxia Research (ICAR), where 
      Quince presented data from its Phase 3 ATTeST clinical trial. 
 
   -- Completed an initial patient sizing project based on third-party analysis 
      from IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics, 
      which confirmed that the number of diagnosed patients with A-T in the 
      U.S. is estimated to be to approximately 4,600. 
 
   -- Established a SAB comprised of leading experts in biochemistry, neurology, 
      immunology, hematology, pharmacology, and clinical practice uniquely 
      positioned to provide Quince with deep insights and advice to support 
      advancement of the company's drug programs. 

Fiscal Year 2024 Financial Results

   -- Reported cash, cash equivalents, and short-term investments of $40.8 
      million for the fiscal year ended December 31, 2024. Quince expects its 
      existing cash runway to be sufficient to fund the company's capital 
      efficient development plan through Phase 3 NEAT topline results and into 
      2026. The company plans to be opportunistic from a financing perspective 
      to extend its existing cash runway. 
 
   -- Reported research and development (R&D) expenses of $18.6 million for the 
      fiscal year ended December 31, 2024. R&D expenses primarily included 
      costs related to ongoing Phase 3 NEAT clinical trial activities and 
      related manufacturing costs. 
 
   -- Reported general and administrative (G&A) expenses of $17.6 million for 
      the fiscal year ended December 31, 2024. G&A expenses primarily included 
      personnel-related and stock-based compensation expenses, commercial 
      planning and new product planning expenses, and other professional 
      administrative costs. 
 
   -- Reported a net loss of $56.8 million, or a net loss of $1.31 per basic 
      and diluted share, for the fiscal year ended December 31, 2024. Weighted 
      average shares outstanding for the year were 43.3 million. 
 
   -- Reported net cash used in operating activities of $31.9 million for the 
      year ended December 31, 2024. Cash used in operating activities was 
      primarily due to a net loss of $56.8 million for the period, adjusted for 
      $25.4 million of non-cash items, including a $17.1 million goodwill 
      impairment charge, $4.7 million in stock-based compensation, $4.0 million 
      change in the fair value of contingent consideration liabilities, $1.7 
      million change in the fair value of long-term debt, and a net increase in 
      operating assets of $2.6 million, offset by a net increase in accounts 
      payable, and accrued expenses and other current liabilities of $ 2.1 
      million. 
 
   -- Made a cash milestone payment of $5.0 million to EryDel shareholders in 
      the third quarter of 2024 following the achievement of the first patient 
      enrolled in the NEAT study in the second quarter of 2024. 

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 plans and the ability to enroll participants, conduct, and/or complete current and additional studies; expected cash position and operating runway; ability to secure additional funding and financial support, including from grant or opportunistic funding opportunities; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission $(SEC.UK)$ on November 13, 2024, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250324815304/en/

 
    CONTACT:    Media & Investor Contact: 

Stacy Roughan

Quince Therapeutics, Inc.

Vice President, Corporate Communications & Investor Relations

ir@quincetx.com

(END) Dow Jones Newswires

March 24, 2025 16:05 ET (20:05 GMT)