Allowance to extend into 2036 patent claims related to method of treating patients with A-T using the company’s proprietary EryDex process

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 that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 17/083,771 entitled Process for the Preparation of Erythrocytes Loaded With One or More Substances of Pharmaceutical Interest and So Obtained Erythrocytes. The newly allowed application covers the method of treating patients with Ataxia-Telangiectasia (A-T) and provides patent coverage for preparing erythrocytes loaded with one or more substances of pharmaceutical interest using the EryDex process. The first independent claim of this application is not limited to any particular pharmaceutical product and is broader than currently granted parent patent claims. Supplementing the company’s existing U.S. Patent No. 10,849,858, Quince now has issued patents directed to the process for encapsulating erythrocytes with a therapeutic drug as well as a method of treating a patient with encapsulated erythrocytes.

Charles Ryan, J.D., Ph.D., Quince’s President and head of the company’s corporate legal activities and intellectual property portfolio, said, “Our growing intellectual property portfolio strengthens the long-term market position for our lead asset EryDex and further validates our proprietary AIDE technology platform. Importantly, this allowance strengthens market exclusivity and extends our patent claims to 2036 in the U.S. We are very pleased with this Notice of Allowance and intend to continue to prosecute additional patent applications to protect EryDex and our proprietary encapsulation technology.”

Quince expects that the resulting patent will be listable in the U.S. Food and Drug Administration’s publication Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). As a result, any generic applicant that references EryDex for the treatment of A-T would be required to certify against the company’s patent. This will provide Quince notice of future generic applicants and give the company other stay provisions under applicable provisions of the Hatch-Waxman Act. This protection is in addition to the expected market exclusivity provided by Orphan Drug Designation in the U.S. and Europe.

A Notice of Allowance is issued after the USPTO determines that the prosecution on the merits of a patent has been completed and grants the patent upon payment of the patent issuance fee. As such, Quince expects the U.S. patent to be issued after administrative processes are complete.

Quince plans to pursue claims having a similar claim scope in related cases pending before the European Patent Office as well.

About Ataxia-Telangiectasia

A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T.

About EryDex for A-T

EryDex 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 EryDex 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.

EryDex 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.

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 company’s patent portfolio, the issuance of patents and related implications for the company; plans to pursue claims, including those currently pending with regulatory agencies, current and future clinical development of EryDex; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; the company’s future development plans and related timing; the company’s focus, objectives, plans, and strategies; and the potential benefits of EryDex, AIDE technology 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) 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.

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