Prelude Therapeutics报告2024年第三季度财务业绩并提供公司更新

展示了PRT3789正在进行的第1期剂量递增研究中的中期数据，这是首个IV SMARCA2降解剂，展示了临床概念验证

在SMARCA4突变癌症患者中，启动了PRT7732的第1期试验，这是首个口服SMARCA2降解剂

展示了下一代降解抗体结合物(Precision ADC)平台的首个临床前数据

将在2024年12月的美国血液学年会上展示PRT2527在血液系统恶性肿瘤中可能最佳的CDK9抑制剂的中期1期临床数据

截至2024年9月30日，现金、现金等价物和可交易证券为$15360万，当前现金储备堪支撑至2026年

2024年9月9日，特拉华州威尔明顿 Nov. 6, 2024 (GLOBE NEWSWIRE) – Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported its financial results for the third quarter ended September 30, 2024 and provided an update on its clinical development pipeline and other corporate developments.

“Our third quarter was marked by dedicated execution and the achievement of essential milestones for our lead clinical programs targeting SMARCA2,” stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. “We have demonstrated the first-ever clinical proof of concept with our first-in-class, highly selective IV SMARCA2 degrader, PRT3789, in patients with aggressive SMARCA4 mutated cancers including non-small cell lung cancer (NSCLC) and esophageal cancers as monotherapy. We also demonstrated an encouraging early safety profile with no overlapping toxicities in our ongoing PRT3789 combination study with docetaxel. We are focused on completing monotherapy dose escalation and rapidly enrolling combination arms to support advancement of PRT3789 into next phase of development, initially in these two cancer types.”

Dr. Vaddi continued, “Additional accomplishments for the quarter include the commencement of patient enrollment for our first-in-class, highly selective oral SMARCA2 degrader, PRT7732 in a biomarker selected phase 1 trial. With two highly differentiated SMARCA2 degraders in the clinic, we are well-positioned to build on our leadership in this novel and important therapeutic

class and provide optionality for patients. We look forward to reporting our progress on both of these programs beginning early 2025.”

Dr. Vaddi also added, “Other milestones for the quarter included presentation of first preclinical data from our Precision ADC program demonstrating the potential of SMARCA2/4 degrader as a potent and effective payload on multiple antibodies, as well as acceptance of interim clinical data in hematological malignancies of our potential best-in-class CDK9 inhibitor, PRT2527 at the American Society of Hematology Meeting in December.”

临床项目更新及即将到来的里程碑

PRT3789-第一个类，高选择性，静脉SMARCA2降解剂

PRT3789旨在治疗SMARCA4突变患者。 SMARCA4突变癌症患者预后不佳。这代表着一个高度未满足医疗需求的领域。

PRT3789处于I期临床开发阶段，用于具有生物标志物选择的SMARCA4突变癌症患者。招募工作仍在计划进行中，公司预计到2024年底结束单药剂量递增，并确定一个剂量用于推进注册试验。此外，正在进行专为NSCLC和SMARCA4功能缺陷突变而富集的回填队列患者的招募工作，以及与紫杉醇联合队列的招募工作也在进行中。公司还启动了一项II期临床试验，评估PRT3789与Keytruda®（pembrolizumab）结合治疗SMARCA4突变癌症患者，根据先前宣布与Merck（在美国和加拿大之外称为MSD）的合作。

KEYTRUDA®是美国默沙东LLC的商标，默沙东公司的附属公司，位于美国新泽西州Rahway。

2024年Q3在医学大会上展示的I期中期数据

公司在ESMO 2024大会上展示了PRT3789在SMARCA4突变癌症患者中I期剂量递增研究的首次中期临床数据更新，并在第36页th 欧洲癌症研究组织-新华保险-美国癌症研究协会研讨会。演示资料可在此处找到 出版物-前奏治疗

据调查人员报道，PRT3789在迄今为止测试的剂量下通常安全且耐受良好。 在26名含有第1类（功能丧失）突变的晚期非小细胞肺癌或食管患者中，经过评估有效性的结果，RECISt确认有4名患者出现了部分缓解（PR），其中2名是食管癌，2名是非小细胞肺癌。 在接受283毫克或更高剂量处理的9名具有第1类突变的患者中，有两名出现了RECISt确认的部分缓解，两者都是非小细胞肺癌患者。 对第1类和第2类SMARCA4突变患者观察到肿瘤缩小。 研究中的其他患者表现出临床益处，表现为持续稳定疾病，其中包括一名持续稳定且进行中的晚期非小细胞肺癌患者，这名患者治疗已超过一年。

试验中展示了对PRT3789与紫杉醇联合递增剂量组的评估患者安全性的初步观察。迄今为止，PRT3789与紫杉醇的联合应用显示出可接受的安全性概况，未报道剂量限制性毒性或研究药物严重不良事件。

PRT7732-一种有效的，高度选择性且口服可生物利用的SMARCA2降解剂

PRT7732是一种高度选择性的口服可生物利用的SMARCA2降解剂。 公司启动并招募了我们针对SMARCA4突变癌症的生物标志物选择性的PRT7732（NCT06560645）多剂量递增试验中的首批患者。

辉瑞点燃合作

Prelude has entered into a collaboration agreement with Pfizer Ignite enabling streamlined access to Ignite services in support of Prelude’s SMARCA2 degrader development programs. Per Pfizer, Ignite is a service offering providing partners access to Pfizer’s significant resources, scale and expertise in developing potentially breakthrough medicines. Under the terms of the collaboration agreement, Prelude retains full ownership and global license rights to all of its programs.

Precision ADC with SMARCA2/4 dual degrader payload

Prelude is developing potent SMARCA2/4 dual degraders that robustly inhibit cancer cell growth and induce cell death across multiple cancer types. The Company presented the first preclinical data from its Precision ADC platform at the 36th EORTC-NCI-AACR Symposium in October. The data demonstrated potent activity of a SMARCA 2/4 degrader payload when conjugated to a range of commercially available antibodies, including PSMA, TROP2, C-MEt, CEACAM5, and CD33. The SMARCA2/4 degrader payload conjugated to an anti-PSMA antibody demonstrated tumor regressions and significantly better ，为抑郁症、焦虑症和其他沉思性障碍提供了有前景的新疗法。 efficacy compared to a traditional PSMA-targeted cytotoxic ADC in xenograft models of prostate cancer at well tolerated doses. The presentation can be found at Publications - Prelude Therapeutics.

PRT2527是一种强效和高选择性的CDK9抑制剂

PRT2527是一种强效和高选择性的CDK9抑制剂，有望避免其他选择性较低的CDK9抑制剂观察到的非靶向毒性。公司目前正在推进PRT2527作为单药在淋巴和髓样血液恶性肿瘤中的应用，以及与zanubrutinib联合治疗b细胞恶性肿瘤.

预计PRT2527将于今年完成b细胞恶性肿瘤的单药剂量递增。髓样恶性肿瘤的剂量递增启动将在2024年上半年进行。 PRT2527在血液恶性肿瘤中的中期1期临床数据，受关注的CDK9抑制剂，将于2024年12月美国血液学年会上进行介绍。

2024年第三季度财务结果 

现金、现金等价物和有价证券：

2024年9月30日，现金、现金等价物和有价证券达15360万美元。公司预计其现有的现金、现金等价物和有价证券将资助Prelude的运营至2026年。

研发费用：

截至2024年第三季度，研发支出从2630万美元增加到2950万美元，较上年同期。2024年9月30日结束的三个月的研发支出中包括340万美元的与股票补偿支出相关的非现金支出，包括员工股票期权，而2023年9月30日结束的三个月为330万美元。研发费用的增加主要是由于支持我们临床前和临床项目的化学、制造和控制（CMC）成本的增加。我们预计我们的研发支出会因临床开发活动的时间安排而在季度间有所变化。

2024年第三季度，一般和行政费用从710万美元增加到790万美元，较上年同期。2024年9月30日结束的三个月的一般和行政费用中包括250万美元的与股票补偿支出相关的非现金支出，包括员工股票期权，而2023年9月30日结束的三个月为340万美元。一般和行政费用的增加主要是由于支付专业费用以支持我们研发工作的增加所致。

全年总行政费用为2940万美元，截至2021年12月31日，相比之下，截至2020年12月31日全年总行政费用为2180万美元。2021年的增加主要是由于股权激励费用的增加，包括510万美元的增量股权激励费用，涉及到前任首席执行官在2021年11月的股权奖励修改，还有薪资和相关费用、法律费用和保险费用的增加，部分抵消了顾问费用和商业费用的减少。

截至2024年9月30日的三个月，净亏损为3230万美元，每股亏损0.43美元，较上年同期的3060万美元，每股亏损0.45美元，有所增加。2024年9月30日结束的季度的净亏损中包括590万美元的与股权支付支出（包括员工股票期权）相关的非现金支出，而2023年同期为670万美元。

持续运营的净亏损为2024年3月31日结束的三个月为2080万美元，而去年同期为7620万美元。净亏损与比较前一季度相比减少了5540万美元，主要是由于毛利润增加了2730万美元，营业费用减少了110万美元，其他费用减少了2940万美元。

2024年第三季度，研发费用由2630万增加到2950万美元，较上年同期。2024年9月30日结束的三个月的研发费用中包括340万与股票补偿支出相关的非现金支出，包括员工期权，而2023年9月30日结束的三个月为330万。研发费用的增加主要是由于支持我们临床前和临床项目的化学、制造和控制（CMC）成本的增加。我们预计我们的研发支出会因临床开发活动时间安排的不同而有所变化。 2024年第三季度，一般和行政费用由710万增加到790万美元，较上年同期。2024年9月30日结束的三个月的一般和行政费用中包括250万与与员工股票期权相关的非现金支出，而2023年9月30日结束的三个月为340万。一般和行政费用的增加主要是由于支付支持我们研发工作而产生的专业费用上升所致。

关于prelude therapeutics

Prelude Therapeutics is a leading precision oncology company developing innovative medicines in areas of high unmet need for cancer patients. Our pipeline is comprised of several novel drug candidates including first-in-class, highly selective IV and oral SMARCA2 degraders, and a potentially best-in-class CDK9 inhibitor. We are also leveraging our expertise in targeted protein degradation to discover, develop and commercialize next generation degrader antibody conjugates (Precision ADCs) with partners. We are on a mission to extend the promise of precision medicine to every cancer patient in need. Our corporate presentation can be found at Events & Presentations - Prelude Therapeutics. For more information, visit preludetx.com.

关于前瞻性声明的警示说明

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities for Prelude’s product candidates, the potential safety, efficacy, benefits and addressable market for Prelude’s product candidates, the expected timeline for initial proof-of-concept data and clinical trial results for Prelude’s product candidates, and the sufficiency of Prelude’s cash runway into 2026. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” “schedule,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These

forward-looking statements are predictions based on the Company’s current expectations and projections about future events and various assumptions. Although Prelude believes that the expectations reflected in such forward-looking statements are reasonable, Prelude cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Prelude's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Prelude's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Prelude’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Prelude's ability to fund development activities and achieve development goals, Prelude's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in Prelude’s Annual Report on Form 10-k for the year ended December 31, 2023, its Quarterly Reports on Form 10-Q and other documents that Prelude files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Prelude undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as may be required by law. 

prelude therapeutics公司

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prelude therapeutics incorporated

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