South San Francisco, California April 1, 2024–(BUSINESS WIRE)–A late-stage biotech company developing innovative drug delivery technologies designed to leverage a patient’s own biology to deliver rare disease treatments Quince Therapeutics, Inc. (NASDAQ: QNCX) today reported its development pipeline and financial results for the fourth quarter and fiscal year ended December 31, 2023.
“With our acquisition of EryDel SpA last October, we are pleased to announce that we are a Phase 3 biotech company dedicated to securing regulatory approval for our lead product, EryDex, for the treatment of patients with ataxia telangiectasia (AT).” We have successfully transitioned our strategic focus to become a technology company,” said Dirk Thye, MD, Quince’s Chief Executive Officer and Chief Medical Officer. “With $75.1 million in cash on hand, we will be able to expand EryDex into other indications and support new products from our autologous intracellular drug encapsulation (AIDE) technology platform, as well as advance Phase 3 clinical trials. We hope that we will have enough funding to complete. By delivering drugs encapsulated in patients’ own red blood cells, we will be able to develop new treatments for chronic corticosteroid therapy, first for chronic corticosteroid therapy, and later for other drugs. We are working to redefine the standard of care to meaningfully improve the quality of life for patients with rare diseases.”
Pivotal Phase 3 NEAT Clinical Trial
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NEAT is an international, multicenter, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of the company’s lead asset, EryDex (dexamethasone sodium phosphate). [DSP] encapsulated in autologous red blood cells), AT patients.
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Participants will be randomly assigned (1:1) between EryDex and placebo, and treatment will consist of six injections scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by change in the rescored Modified International Cooperative Ataxia Rating Scale (RmICARS) from baseline to completion of the final visit.
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Participants who complete the entire treatment period, complete study assessments, and provide informed consent will be eligible to proceed to the open-label extension study.
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Quince estimates that there are a total of approximately 10,000 people with AT in the United States, United Kingdom, and four EU countries.
Science, pipeline and company updates
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Optimized DSP delivery of EryDex encapsulated in red blood cells is detailed by comparing company data with published corticosteroid pharmacokinetic and biodistribution information. Red blood cells have several properties that may make them ideal vehicles for drug delivery, including improved tolerability, enhanced tissue distribution, reduced immunogenicity, and extended circulating half-life. Learn more about.
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We intend to investigate other potential indications for EryDex where chronic corticosteroid therapy is or could become the standard of care absent corticosteroid-related safety concerns. This evaluation process is expected to span ataxia, neuromuscular diseases, hematology, cancer, and autoimmune diseases, with a focus on rare diseases.
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Continued involvement of global patient advocacy organizations as enrollment progresses for the Phase 3 NEAT study, as well as participation in several AT-related global ataxia and neurology conferences in 2024. is the goal.
Strong cash position expected to support meaningful clinical milestones
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As of December 31, 2023, we reported cash, cash equivalents and short-term investments of $75.1 million. Quince expects existing capital to be sufficient to fund the company’s capital efficient development plans through 2026.
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We plan to fully fund our lead asset, EryDex, through the topline results of Phase 3 NEAT and prepare for a potential NDA filing in 2026, subject to positive study results. This includes approximately $20 million for the NEAT study and approximately $15 million in direct trial costs for the open-label extension.
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outside the U.S. to expand operational runway to support potential NDA approval for EryDex, as well as to further advance other potential indications and programs discovered using the AIDE platform. Evaluate the potential for strategic partnerships to license out to regional territories.
About Quince Therapeutics
Quince Therapeutics (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the potential of patients’ own biology and delivering innovative, life-changing treatments to people with rare diseases. To learn more about the company and its latest news, please visit www.quincetx.com and follow Quince Therapeutics on social media platforms LinkedIn, Facebook, and Quince Therapeutics. Twitter/X.
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. Masu. These are subject to the “safe harbor” created by those sections. All statements other than statements of historical fact may be forward-looking statements. Forward-looking statements contained in this news release “believe,” “may,” “should,” “expect,” “forecast,” “plan,” “believe,” “estimate” may be identified by the use of words such as “will” or “predict”. “‘may,’ ‘intend,’ ‘plan,’ ‘could,’ ‘seek,’ or other similar words.” Examples of forward-looking statements include, among other things, the pivotal trial for ataxia telangiectasia, the potential commercial inflection point for EryDex, and the expansion of the company’s proprietary autologous intracellular drug encapsulation; Contains statements regarding current and future clinical developments for EryDex. (AIDE) Technologies for the treatment of other rare diseases. EryDex’s strategic development path. planned regulatory filings, clinical trials, timelines, prospects and milestone expectations; related data, including the timing and success of clinical trials and our plans and ability to initiate, fund, conduct and/or complete current and additional studies; Research and development expenses. timing in relation to the Company’s future development plans; Cash position and expected cash runway. A company’s focus, objectives, plans, and strategies. and the company’s market opportunities. 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 may cause actual results to differ materially from the Company’s expectations. Additionally, certain forward-looking statements are based on assumptions about future events that may not prove to be accurate. Some of the factors that could cause actual results to differ include those 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). including, but not limited to, risks and uncertainties. November 14, 2023, and other reports filed with the SEC. The forward-looking statements contained in this news release are made as of the date hereof, and Quince undertakes no obligation to update such information except as required by applicable law. yeah.
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contact address
Media and Investor Contact:
stacey rowan
Quince Therapeutics, Inc.
Vice President of Corporate Communications and Investor Relations
ir@quincetx.com
