- Phase 3 BOND-003 study results showed sustained, durable complete responses over 12 months with novel investigational oncolytic immunotherapy -

-3期BOND-003研究结果显示，新型研究性溶瘤免疫疗法在12个月内持续，持久的完全反应-

- Company will hold an investor conference call today at 4:30pm EDT -

-公司将于美国东部时间今天下午4:30召开投资者电话会议-

IRVINE, Calif., May 03, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. today announced that data from the Phase 3 BOND-003 study evaluating the efficacy and safety of cretostimogene monotherapy in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG), showed that 75.2% of patients (79 out of 105 [95% confidence interval (CI), 65-83]) achieved a complete response (CR) at any time, as of the cutoff date of April 1, 2024.

加利福尼亚州欧文市，2024年5月3日（环球通讯社）--CG Oncology，Inc.今天宣布，评估cretostimogene单药治疗高危非肌肉浸润性膀胱癌（NMIBC）对卡介苗（BCG）无反应的患者的疗效和安全性的3期BOND-003研究数据显示，截至2024年4月1日的截止日期，75.2%的患者（105名患者中的79名[95%置信区间（CI），65-83]）在任何时候都达到了完全缓解（CR）。

These data were featured today at the Paradigm-Shifting, Practice-Changing Clinical Trials in Urology Plenary Session as an oral presentation (Abstract #24-11358) by Dr. Mark D. Tyson, Urologic Oncologist at Mayo Clinic, at the 2024 American Urological Association (AUA) Annual Meeting, in San Antonio, TX.

这些数据今天在梅奥诊所泌尿科肿瘤学家Mark D.Tyson博士于2024年美国泌尿外科协会（AUA）年会上于德克萨斯州圣安东尼奥举行的泌尿外科全体会议上作为口头报告（摘要#24-11358）在范式转变，改变实践的临床试验中得到了展示。

In addition, cretostimogene has shown durable responses over time with twenty-nine patients maintaining a complete response for 12 months or more, pending evaluation and assessment of ongoing responses in twenty-two patients as of the data cutoff. Median duration of response (DOR) was not reached. 92.4% cystectomy-free survival was observed and none of the patients with a complete response had undergone radical cystectomy or showed nodal or metastatic progression..

此外，cretostimogene随着时间的推移显示出持久的反应，29名患者在12个月或更长时间内保持完全反应，等待评估和评估截至数据截止时22名患者的持续反应。未达到中位反应持续时间（DOR）。观察到92.4%的无膀胱切除术生存率，完全缓解的患者均未接受根治性膀胱切除术或显示淋巴结或转移进展。。

Cretostimogene is an investigational oncolytic immunotherapy which has shown selective oncolysis and potent anti-tumor immune response, and is being evaluated in BOND-003 (NCT04452591), a single-arm, Phase 3, monotherapy clinical trial for the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in-situ (CIS) with or without Ta or T1 papillary tumors.

Cretostimogene是一种研究性溶瘤免疫疗法，已显示出选择性溶瘤和有效的抗肿瘤免疫反应，目前正在BOND-003（NCT04452591）中进行评估，BOND-003是一项单臂3期单药治疗临床试验，用于治疗高危BCG无反应性NMIBC伴原位癌（CIS）伴或不伴Ta或T1乳头状肿瘤的患者。

The fully enrolled global trial with a total of 112 patients is currently ongoing in North America and the Asia-Pacific region. The primary endpoint of the study is CR at any time, with DOR measured as a secondary endpoint. The highly pre-treated study population includes patients with prior intravesical chemotherapy and systemic immunotherapy..

目前，北美和亚太地区正在进行总共112名患者的全面登记的全球试验。该研究的主要终点是任何时候的CR，DOR作为次要终点。高度预处理的研究人群包括先前接受过膀胱内化疗和全身免疫治疗的患者。。

There were no Grade 3 or higher treatment-related adverse events (TRAEs) or deaths reported, and two patients (1.8%) had serious TRAEs (Grade 2). No treatment-related discontinuation of cretostimogene was observed. 94.5% of patients completed all expected treatments. TRAEs occurred in 70 patients (62.5%).

没有报告3级或更高级别的治疗相关不良事件（TRAEs）或死亡，两名患者（1.8%）患有严重的TRAEs（2级）。没有观察到与cretostimogene治疗相关的停药。94.5%的患者完成了所有预期的治疗。TRAEs发生率为70例（62.5%）。

The most common TRAEs (≥10%) were bladder spasm, pollakiuria, dysuria, micturition urgency, and hematuria, as of the safety cutoff date of January 31, 2024..

截至2024年1月31日的安全截止日期，最常见的TRAE（≥10%）是膀胱痉挛，pollakiuria，排尿困难，排尿急迫和血尿。。

“The positive 12-month BOND-003 data presented at AUA 2024, with a notable duration of response, reinforces cretostimogene monotherapy as a potential backbone therapy in the NMIBC treatment landscape for BCG-unresponsive patients. This innovative immunotherapy candidate may, if approved, emerge as a favored option for patients over the surgical extraction of their bladder, as they face limited options,” said Gary D.

Gary D.说：“AUA 2024年会议上公布的12个月BOND-003阳性数据显示，反应持续时间显著，这加强了cretostimogene单一疗法作为卡介苗无反应患者NMIBC治疗领域潜在的骨干疗法。如果获得批准，这种创新的免疫治疗候选药物可能会成为患者手术切除膀胱的首选方案，因为他们面临的选择有限。”。

Steinberg, M.D., Professor, Department of Urology at Rush University Medical Center. “Cretostimogene reported remarkable interim efficacy results, with over half of the patients experiencing complete responses upon repeat induction. There continues to be a need for new options for patients with bladder cancer.”.

斯坦伯格医学博士，拉什大学医学中心泌尿系教授。“Cretostimogene报告了显着的中期疗效结果，超过一半的患者在重复诱导后经历了完全的反应。膀胱癌患者仍然需要新的选择。”。

“We’re thrilled to present today’s updated data which reinforces cretostimogene’s potential as a bladder-sparing therapeutic that could materially improve both patient outcomes and quality of life,” said Ambaw Bellete, President & Chief Operating Officer, CG Oncology. “Importantly, with topline data expected from BOND-003 by the end of 2024, we look forward to a regulatory approval submission.”.

CG肿瘤学总裁兼首席运营官Ambaw Bellete说：“我们很高兴能提供今天的最新数据，这些数据增强了cretostimogene作为膀胱保留疗法的潜力，可以大大改善患者的预后和生活质量。”。“重要的是，预计到2024年底，BOND-003将发布最新数据，我们期待监管部门的批准。”。

Last December, the U.S. Food and Drug Administration (FDA) granted both Fast Track Designation and Breakthrough Therapy Designation for cretostimogene in high-risk BCG-unresponsive NMIBC with carcinoma in-situ with or without Ta or T1 papillary tumors.

去年12月，美国食品和药物管理局（FDA）批准了cretostimogene的快速通道指定和突破性治疗指定，用于高危BCG无反应的NMIBC，伴有或不伴有Ta或T1乳头状肿瘤的原位癌。

Investor Conference Call

投资者电话会议

CG Oncology will host a conference call and live webcast at 4:30pm EDT today on May 3, 2024. Individuals interested in listening to the live conference call may do so by using the webcast link in the “Investor Relations' section of the company's website at https://ir.cgoncology.com. A webcast replay will be available in the investor relations section on the company's website following the completion of the call..

CG肿瘤学将于2024年5月3日美国东部夏令时下午4:30主持电话会议和网络直播。有兴趣收听现场电话会议的个人可以使用公司网站“投资者关系”部分的网络广播链接https://ir.cgoncology.com.通话结束后，将在公司网站的投资者关系部分提供网络广播重播。。

About Cretostimogene Grenadenorepvec

关于Cretostimogene Grenadenorepvec

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy. Cretostimogene was previously evaluated in a Phase 2 clinical trial (CORE-001) in combination with pembrolizumab in the same indication and is also being evaluated in a Phase 3 monotherapy clinical trial (PIVOT-006) in intermediate-risk NMIBC patients.

Cretostimogene是一种研究性的膀胱内溶瘤免疫疗法，正在BOND-003中进行评估，BOND-003是一项3期临床试验，用于治疗对卡介苗（BCG）治疗无反应的高危非肌肉浸润性膀胱癌（NMIBC）患者。Cretostimogene先前在2期临床试验（CORE-001）中与pembrolizumab联合使用相同的适应症进行了评估，并且还在中危NMIBC患者的3期单药治疗临床试验（PIVOT-006）中进行了评估。

In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer..

此外，cretostimogene正在一项由研究者赞助的临床试验中与nivolumab联合用于治疗肌肉浸润性膀胱癌。。

About the BOND-003 Clinical Study

关于BOND-003临床研究

BOND-003 (NCT04452591) is a single-arm, open-label, Phase 3 clinical trial evaluating cretostimogene as monotherapy in patients with high-risk NMIBC unresponsive to BCG therapy. The study fully enrolled 112 evaluable patients with BCG-unresponsive NMIBC across North America and the Asia-Pacific region..

BOND-003（NCT04452591）是一项单臂开放标签的3期临床试验，评估cretostimogene作为单一疗法治疗对卡介苗治疗无反应的高危NMIBC患者。该研究在北美和亚太地区招募了112名卡介苗无反应的NMIBC可评估患者。。

About Bladder Cancer

关于膀胱癌

More than 83,000 people are estimated to be diagnosed with bladder cancer in 2024. NMIBC is the most common form of bladder cancer, representing approximately 75% of newly diagnosed cases. Bladder cancer is the sixth most common form of cancer in the United States, and men account for three quarters of newly diagnosed cases..

2024年，估计有83000多人被诊断出患有膀胱癌。NMIBC是最常见的膀胱癌形式，约占新诊断病例的75%。膀胱癌是美国第六大常见癌症，男性占新诊断病例的四分之三。。

About CG Oncology

关于CG肿瘤学

CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life.

CG Oncology是一家晚期临床生物制药公司，专注于为患有膀胱癌的患者开发和商业化潜在的骨干膀胱保留疗法。CG肿瘤学认为，泌尿系统癌症患者可能会受益于我们的创新免疫疗法，从而有尊严地生活并提高生活质量。

To learn more, please visit: www.cgoncology.com..

要了解更多信息，请访问：www.cgonology.com。。

Forward-Looking Statements

前瞻性声明

CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients and the expected timing of final data for the BOND-003 trial.

CG Oncology提醒您，本新闻稿中关于非历史事实的声明是前瞻性声明。前瞻性声明基于我们目前的信念和期望，包括但不限于cretostimogene对高危和中危NMIBC患者的潜在治疗益处以及BOND-003试验最终数据的预期时间。

Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment, data readout and completion of clinical trials, including the BOND-003 trial; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the SEC, including under the heading “Risk Factors” in our annual report on Form 10-K and any subsequent filings with the SEC.

由于我们业务中固有的风险和不确定性，实际结果可能与本新闻稿中列出的结果不同，包括但不限于：临床试验的中期结果不一定表示最终结果，随着患者登记的继续，对数据进行更全面的审查，以及随着更多患者数据的出现，一个或多个临床结果可能会发生重大变化；包括BOND-003试验在内的临床试验的开始，登记，数据读取和完成的潜在延迟；我们在制造，运输以及临床和临床前测试方面依赖第三方；早期临床试验和临床前研究的结果不一定能预测未来的结果；cretostimogene的意外不良副作用或功效不足，可能会限制其开发，监管批准和/或商业化；以及我们向美国证券交易委员会提交的文件中描述的其他风险，包括我们在10-K表年度报告中的“风险因素”标题下以及随后向美国证券交易委员会提交的任何文件。

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the da.

提醒您不要过度依赖这些前瞻性声明，这些声明仅在本协议签署之日起生效，我们没有义务更新这些声明以反映da之后发生的事件或情况。

Contacts

联系人

Investor Relations

投资者关系

Laurence Watts

劳伦斯·瓦茨

New Street IR

新街道IR

(619) 916-7620

(619) 916-7620

IR@cgoncology.com

IR@cgoncology.com

Media

媒体

Kimberly Ha

金伯利Ha

KKH Advisors

KKH顾问

(917) 291-5744

(917) 291-5744

kimberly.ha@kkhadvisors.com

kimberly.ha@kkhadvisors.com