SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology that leverages a patient’s own biology to deliver rare disease therapeutics, announced the successful completion of its acquisition of EryDel S.p.A., a privately-held, late-stage biotech company.

南旧金山，加利福尼亚州-（商业线）-Quince Therapeutics，Inc。（纳斯达克股票代码：QNCX），一家开发创新药物输送技术的晚期生物技术公司，利用患者自身的生物学提供罕见疾病治疗，宣布成功完成收购EryDel s.p.a.，这是一家私营的后期生物技术公司。

Quince’s newly acquired Phase 3 lead asset, EryDex, targets a rare neurodegenerative disease, Ataxia-Telangiectasia (A-T). Currently, there are no approved treatments for A-T and the market represents a $1+ billion estimated peak sales opportunity globally. EryDex utilizes a highly differentiated and proprietary technology platform for autologous intracellular drug encapsulation (AIDE), which is designed to optimize the biodistribution of dexamethasone sodium phosphate (DSP; a pro-drug) by using an A-T patient’s own red blood cells to deliver the sustained therapeutic over a once monthly treatment period..

Quince新收购的3期主要资产EryDex针对一种罕见的神经退行性疾病，共济失调毛细血管扩张症（a-T）。目前，尚无批准的A-T治疗方法，该市场代表全球估计的10多亿美元的峰值销售机会。EryDex利用高度分化和专有的技术平台进行自体细胞内药物包封（AIDE），旨在通过使用a-T患者自身的红细胞来优化地塞米松磷酸钠（DSP；前药）的生物分布持续治疗每月一次的治疗期。。

“The successful closing of the EryDel acquisition is an exciting step forward in fulfilling our vision to build a leading rare disease biotechnology company,” said Dirk Thye, M.D., Quince’s Chief Executive Officer. “We are dedicated to developing treatments utilizing our proprietary AIDE technology platform that hold the potential to help children and families affected by rare and debilitating diseases such as A-T.

Quince首席执行官Dirk Thye博士说：“成功完成EryDel收购是实现我们建立领先的罕见病生物技术公司愿景的一个令人兴奋的一步。“我们致力于利用专有的助手技术平台开发治疗方法，该平台具有帮助受罕见和使人衰弱的疾病（例如A-T）影响的儿童和家庭的潜力。

Quince’s priority is to advance the Phase 3 clinical trial of EryDex to evaluate its safety and efficacy for the treatment of A-T, then expand our development efforts into other potential indications that leverage our proprietary AIDE technology platform.”.

Quince的首要任务是推进EryDex的3期临床试验，以评估其治疗A-T的安全性和有效性，然后将我们的开发工作扩展到利用我们专有的助手技术平台的其他潜在适应症。

Quince is well-capitalized into 2026 and intends to focus its development expertise and financial resources toward advancing a single global Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T) clinical trial, which is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of EryDex on patients with A-T.

Quince在2026年得到了很好的利用，并打算将其开发专业知识和财政资源集中用于推进单一的全球3期NEAT（EryDex对a-T受试者的神经影响）临床试验，这是一项多中心，随机，双盲，安慰剂对照研究，以评估EryDex对a-T患者的神经影响。

Enrollment for the Phase 3 NEAT trial is expected to begin in the second quarter of 2024. The company plans to enroll approximately 86 A-T patients aged six to nine years-old and approximately 20 additional A-T patients aged 10 years or older. This pivotal clinical trial will be conducted under a Special Protocol Assessment (SPA) that has been agreed with the U.S.

预计第3阶段NEAT试验的入学将于2024年第二季度开始。该公司计划招募大约86名6至9岁的A-T患者和约20名10岁或以上的A-T患者。这项关键的临床试验将在与美国达成一致的特殊方案评估（SPA）下进行。

Food & Drug Administration (FDA), which should allow for the submission of a New Drug Application (NDA) following completion of this single study, assuming positive results..

食品药品监督管理局（FDA），该研究应允许在完成本项研究后提交新药申请（NDA），并取得积极成果。。

Quince’s integrated senior leadership team holds extensive development, clinical, regulatory, and commercial expertise, and includes:

Quince的综合高级领导团队拥有广泛的发展，临床，监管和商业专业知识，包括：

Dirk Thye, M.D. – Chief Executive Officer and member of Quince’s Board of Directors

Dirk Thye，M.D.-首席执行官和Quince董事会成员

Charles Ryan, J.D., Ph.D. – President

Charles Ryan，J.D.，Ph.D.–总裁

Guenter R. Janhofer, M.D., Ph.D. – Chief Medical Officer

Guenter R.Janhofer，M.D.，博士-首席医疗官

Brendan Hannah, M.B.A. – Chief Business Officer and Principal Financial Officer

Brendan Hannah，M.B.A.-首席商务官和首席财务官

Giovanni Mambrini, MSc – Chief Technology Officer

Giovanni Mambrini，理学硕士-首席技术官

Thomas Sabia, M.B.A. – Chief Commercial Officer

Thomas Sabia，M.B.A.-首席商业官

Pamela Williamson, RAC, FRAPS, M.B.A. – Head of Regulatory Affairs

Pamela Williamson，RAC，FRAPS，M.B.A.-监管事务负责人

EryDel’s former Chief Executive Officer, Luca Benatti, Ph.D., also joins Quince’s Board of Directors.

EryDel的前首席执行官Luca Benatti博士也加入了Quince的董事会。

The acquisition of EryDel was completed with no upfront cash payment, using a stock-for-stock exchange and potential downstream milestone cash payments. EryDel stockholders now own 15.2% of Quince’s outstanding shares and may be issued up to an additional 725,036 shares of the company’s common stock (equal to 16.6% of Quince’s currently outstanding shares – inclusive of the shares issued) upon the first anniversary of the transaction closing.

收购EryDel完成时没有现金支付，使用股票交换和潜在的下游里程碑现金支付。EryDel股东现在拥有Quince已发行股的15.2%，并且可以在交易结束一周年后再发行公司普通股的725036股（相当于Quince目前已发行股的16.6%（包括已发行股）。

EryDel stockholders also will be entitled to up to $485 million in potential total downstream cash payments, including up to $5 million in development milestones, $25 million at NDA acceptance, $60 million in approval milestones, and $395 million on market and sales milestones, with no royalties paid to EryDel stockholders.

EryDel股东还将有权获得高达4.85亿美元的潜在下游现金支付总额，包括高达500万美元的发展里程碑，2500万美元的NDA接受，6000万美元的批准里程碑以及3.95亿美元的市场和销售里程碑，没有版税支付给EryDel股东。

The transaction includes the assumption of EryDel’s $13 million (€10 million in principal) European Investment Bank (EIB) loan with scheduled payments beginning in the second half of 2026..

该交易包括假设EryDel的1300万美元（原则上1000万欧元）欧洲投资银行（EIB）贷款，计划于2026年下半年开始支付。。

About Quince Therapeutics

关于奎因疗法

Quince Therapeutics (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology to deliver innovative and life-changing therapeutics to those living with rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince Therapeutics on social media platforms LinkedIn and X..

Quince Therapeutics（纳斯达克股票代码：QNCX）是一家后期生物技术公司，致力于释放患者自身生物学的力量，为患有罕见疾病的人提供创新和改变生活的疗法。有关公司及其最新消息的更多信息，请访问www.quincetx.com，并在LinkedIn和X.的社交媒体平台上关注Quince Therapeutics。。

Forward-looking Statements

前瞻性声明

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.

本新闻稿中的陈述包含1933年“证券法”第27A条（经修订）和1934年“证券交易所法”第21E条所载1995年“私人证券诉讼改革法”含义内的“前瞻性陈述”。经修订，受这些部分创建的“安全港”的约束。

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.

除历史事实陈述外，所有陈述都可能是前瞻性陈述。本新闻稿中包含的前瞻性陈述可以通过使用诸如“相信”，“可能”，“应该”，“期望”，“预期”，“计划”，“相信”，“估计”，“潜在”，“打算”，“将会”，“可以”，“寻求”或其他类似的词语。

Examples of forward-looking statements include, among others, statements relating to Quince’s acquisition of EryDel; the expected benefits of the transaction, including the continued current and future clinical development and potential expansion of EryDel assets, related platform, and related timing and costs; the strategic development path for EryDex; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; the timing and success of the clinical trials and related data, including plans and the ability to initiate, fund, conduct and/or complete current and additional studies; the potential therapeutic benefits, safety, and efficacy of EryDex; statements about its ability to obtain, and the timing relating to, further development of EryDex; therapeutic and commercial potential; the integration of EryDel’s business, operations, and employees into Quince; Quince’s future development plans and related timing; its cash position and projected cash runway; the company’s focus, objectives, plans, and strategies; and the ability to execu.

前瞻性陈述的例子包括与奎因收购EryDel有关的陈述；交易的预期收益，包括当前和未来的临床开发以及EryDel资产，相关平台以及相关时间和成本的潜在扩张；EryDex的战略发展路径；计划的监管机构提交和临床试验以及时间表，前景和里程碑期望；临床试验和相关数据的时间和成功，包括计划和启动，资助，实施和/或完成当前和其他研究的能力；EryDex的潜在治疗益处，安全性和有效性；关于其获得EryDex的能力以及与EryDex的进一步发展有关的时间的陈述；治疗和商业潜力；将EryDel的业务，运营和员工整合到一起；奎斯特未来的发展计划和相关时机；其现金状况和预计现金跑道；公司的重点，目标，计划和策略；和执行能力。