PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that new data on investigational drug UGN-102 (mitomycin) and JELMYTO and will be presented at the American Urological Association (AUA) 2024 Annual Meeting being held in San Antonio, Texas from May 3 – 6..

新泽西州普林斯顿市——（商业新闻短讯）——UroGen Pharma Ltd.（纳斯达克：URGN）是一家致力于开发和商业化治疗尿路上皮癌和特殊癌症的创新解决方案的生物技术公司，今天宣布，有关研究药物UGN-102（丝裂霉素）和JELMYTO的新数据将于5月3日至6日在德克萨斯州圣安东尼奥举行的美国泌尿外科协会（AUA）2024年会上公布。。

“We are proud that the AUA selected the ATLAS post-hoc analysis as a podium presentation,” said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. “The results highlight UGN-102’s potential to help significantly advance treatment for patients with newly diagnosed and recurrent LG-IR-NMIBC, a highly prevalent and recurrent disease.

UroGen首席医疗官Mark Schoenberg医学博士说：“AUA选择ATLAS事后分析作为讲台演示，我们感到骄傲。”。“研究结果突出表明，UGN-102有助于显着提高新诊断和复发性LG-IR-NMIBC患者的治疗水平，LG-IR-NMIBC是一种高度流行和复发的疾病。

Additionally, we are excited to see additional independent real-world evidence related to JELMYTO treatment of LG-UTUC patients in a diverse patient types.”.

此外，我们很高兴看到与JELMYTO治疗不同患者类型的LG-UTUC患者有关的其他独立现实世界证据。”。

Key details of UGN-102 and JELMYTO abstracts accepted by AUA:

AUA接受的UGN-102和JELMYTO摘要的关键细节：

Abstract Title

摘要标题

Presentation Details

演示文稿详细信息

Response to Primary Chemoablation with UGN-102 in Patients with New or Recurrent LG IR NMIBC: Post-hoc Analysis of the ATLAS Trial

新发或复发性LG-IR NMIBC患者对UGN-102初次化学消融的反应：ATLAS试验的事后分析

Podium Oral Presentation:

讲台口头陈述：

Abstract ID 24-6641,

摘要ID 24-6641，

Saturday, May 4,

5月4日，星期六，

2:20-2:30 PM CDT,

2： CDT下午20-2:30，

Location 304A

位置304A

Presenter: Dr. William Huang

主持人：William Huang博士

Longitudinal Follow Up of Multicenter Study of UGN-101 for Upper Tract Urothelial Cancer

UGN-101治疗上尿路上皮癌多中心研究的纵向随访

Podium Oral Presentation:

讲台口头陈述：

Abstract ID 24-7470,

摘要ID 24-7470，

Sunday, May 5,

5月5日，星期日，

11:10-11:20 AM CDT,

11： CDT上午10-11:20，

Location 301A

位置301A

Presenter: Dr. Yair Lotan

主持人：Yair Lotan博士

Exploring Recurrence After Initial Response to UGN-101 Induction in Expanded Settings

在扩大的环境中探索对UGN-101诱导的初始反应后的复发

Podium Oral Presentation:

讲台口头陈述：

Abstract ID 24-7534,

摘要ID 24-7534，

Sunday May 5,

5月5日星期日，

11:20-11:30 AM CDT,

11： CDT上午20-11:30，

Location 301A

位置301A

Presenter: Dr. Adam Feldman

主持人：Adam Feldman博士

Mitomycin-containing Reverse Thermal Gel UGN-101 for Upper Tract Urothelial Carcinoma: Retrograde Instillation in Clinic and Outcomes

含丝裂霉素的反向热凝胶UGN-101治疗上尿路上皮癌：临床逆行滴注和结果

Video Presentation:

视频演示：

Abstract ID 24-7720,

摘要ID 24-7720，

Saturday, May 4,

5月4日，星期六，

10:50-11:00 AM CDT,

10： CDT上午50-11:00，

Location Video Abstract Theater

位置视频摘要影院

Presenter: Dr. Golena Moncaleano

主持人：Golena Moncaleano博士

UroGen Sponsors AUA Innovation Nexus

UroGen赞助商AUA创新关系

UroGen’s President and Chief Executive Officer, Liz Barrett, will participate in a panel discussion about the state of innovation in urology and a reverse pitch on key areas of discovery and collaboration during the AUA Innovation Nexus Conference on May 2. The AUA Innovation Nexus is a powerful forum to advance urologic discovery to solutions that improve patient care and save lives.

UroGen总裁兼首席执行官利兹·巴雷特（LizBarrett）将在5月2日举行的AUA创新关系会议上，参加关于泌尿科创新状况的小组讨论，并就发现和合作的关键领域进行反向宣传。AUA Innovation Nexus是一个强大的论坛，可以促进泌尿外科发现，从而改善患者护理和挽救生命。

Register here: https://auanexus.org/innovation-nexus-conference/registration.

在此处注册：https://auanexus.org/innovation-nexus-conference/registration.

State of Innovation in Urology

泌尿外科的创新状态

Reverse Pitch:

反向变桨：

1-2 PM CDT

下午1-2点CDT

Showcase Panel:

Showcase面板：

Thursday May 2 between 2:45-4:45 PM CDT

CDT时间5月2日星期四下午2:45-4:45

Liz Barrett, President and CEO, UroGen Pharma & Other Speakers

利兹·巴雷特，UroGen Pharma总裁兼首席执行官及其他发言人

About UGN-102

关于UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.

用于膀胱内溶液的UGN-102（丝裂霉素）是丝裂霉素的创新药物制剂，目前处于用于治疗LG-IR-NMIBC的3期开发中。UGN-102利用UroGen专有的RTGel®技术（一种基于水凝胶的缓释制剂）设计用于使膀胱组织更长时间暴露于丝裂霉素，从而能够通过非手术手段治疗肿瘤。

UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates completing its new drug application (NDA) submission for UGN-102 in September 2024 with a potential FDA decision as early as the first quarter of 2025..

UGN-102在门诊使用标准导尿管输送给患者。假设ENVISION 3期研究的反应终点的持久性得到了积极的发现，UroGen预计将于2024年9月完成其UGN-102新药申请（NDA）提交，最早可能在2025年第一季度做出FDA决定。。

About Non-Muscle Invasive Bladder Cancer (NMIBC)

关于非肌层浸润性膀胱癌（NMIBC）

In the U.S. bladder cancer is the second most common urologic cancer in men. LG-IR-NMIBC represents approximately 22,000 newly diagnosed bladder cancer patients each year and an estimated existing 60,000 recurrent patients. Bladder cancer primarily affects older populations with the median age of diagnosis 73 years and an increased risk of comorbidities.

在美国，膀胱癌是男性第二常见的泌尿系统癌症。LG-IR-NMIBC每年代表大约22000名新诊断的膀胱癌患者，估计现有60000名复发患者。膀胱癌主要影响中位诊断年龄为73岁且合并症风险增加的老年人群。

Guideline recommendations for managing LG-IR-NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence and LG-IR-NMIBC patients are even more likely to recur and face repeat TURBT procedures..

管理LG-IR-NMIBC的指南建议包括经尿道膀胱肿瘤切除术（TURBT）作为护理标准。高达70%的NMIBC患者至少有一次复发，LG-IR-NMIBC患者更有可能复发并面临重复TURBT手术。。

About JELMYTO

关于杰尔米托

JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy.

用于肾盂肾溶液的JELMYTO®（丝裂霉素）是一种含有丝裂霉素的反向热凝胶，每毫升凝胶含有4毫克丝裂霉素，用于治疗成人低度上尿路上皮癌（LG-UTUC）。建议对被认为适合保留肾脏治疗的患者进行活检证实的LG-UTUC的初步治疗。

JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube.

JELMYTO在冷却时是粘性液体，在体温下变成半固体凝胶。该药物在滴注后4至6小时内缓慢溶解，并通过正常的尿流和排尿从尿路中排出。它被批准通过输尿管导管逆行给药或通过肾造口管顺行给药。

The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow..

输送系统允许初始液体涂覆并符合上尿路解剖结构。最终的半固体凝胶允许化学消融疗法在收集系统中保留四到六个小时，而不会立即被尿液稀释或冲走。。

About Upper Tract Urothelial Cancer

关于上尿路上皮癌

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 - 7,000 new or recurrent low-grade UTUC patients annually.

尿路上皮癌是全球第九大常见癌症，也是美国男性第八大致命肿瘤。原发性尿路上皮癌中有5%至10%起源于输尿管或肾盂，统称为上尿路上皮癌（UTUC）。在美国，每年约有6000至7000名新发或复发的低度UTUC患者。

Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse..

大多数病例被诊断为70岁以上的患者，这些老年患者经常面临合并症。UTUC的治疗选择有限，最常见的是内镜手术或肾输尿管切除术（切除整个肾脏和输尿管）。这些治疗可能导致高复发率。。

About UroGen Pharma Ltd.

关于UroGen制药有限公司

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs.

UroGen是一家生物技术公司，致力于开发和商业化治疗尿路上皮癌和特殊癌症的创新解决方案，因为患者应该得到更好的选择。UroGen开发了RTGel反向热水凝胶，这是一种专有的缓释水凝胶平台技术，有可能改善现有药物的治疗效果。

UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat LG-UTUC and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to ablate tumors by non-surgical means.

UroGen的缓释技术旨在使泌尿道组织更长时间暴露于药物，使局部治疗成为潜在的更有效的治疗选择。我们的第一个治疗LG-UTUC的产品和用于低级别非肌肉浸润性膀胱癌患者膀胱内溶液的研究性治疗UGN-102（丝裂霉素）旨在通过非手术手段消融肿瘤。

UroGen is headquartered in Princeton, NJ with operations in Israel. To learn more, visit www.UroGen.com or follow us on X (Twitter), @UroGenPharma..

UroGen总部位于新泽西州普林斯顿，在以色列运营。要了解更多信息，请访问www.UroGen.com或在X（推特），@UroGenPharma上关注我们。。

APPROVED USE FOR JELMYTO

批准用于JELMYTO

JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

JELMYTO®是一种处方药，用于治疗患有上尿路衬里癌症（包括肾脏）的成年人，称为低度上尿路尿路上皮癌（LG-UTUC）。

IMPORTANT SAFETY INFORMATION

重要安全信息

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

如果你的膀胱或上尿路有洞或撕裂（穿孔），你不应该接受杰米托。

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

在接受JELMYTO之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否：

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.

怀孕或计划怀孕。杰尔米托会伤害你的未出生婴儿。在用杰米托治疗期间，你不应该怀孕。如果你怀孕了，或者在服用杰米托期间认为自己可能怀孕了，请立即告诉你的医疗保健提供者。能够怀孕的女性：在使用杰米托治疗期间和最后一剂后6个月内，应使用有效的节育（避孕）。

Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose..

正在接受杰米托治疗的男性：如果你有一位能够怀孕的女性伴侣，你应该在使用杰米托治疗期间以及最后一剂后3个月内使用有效的节育（避孕）。。

are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.

正在母乳喂养或计划母乳喂养。目前还不知道杰米托是否会进入你的母乳。在用JELMYTO治疗期间和最后一次给药后1周内不要母乳喂养。

Tell your healthcare provider if you take water pills (diuretic).

如果你服用水丸（利尿剂），请告诉你的医疗保健提供者。

How will I receive JELMYTO?

我将如何接收杰尔米托？

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.

你的医疗保健提供者会告诉你在每次治疗前服用一种名为碳酸氢钠的药物。

You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

您将每周1次从您的医疗保健提供者处获得JELMYTO剂量，持续6周。重要的是，您必须根据医疗保健提供者的说明接受所有6剂杰米托。如果您错过任何预约，请尽快致电您的医疗保健提供者，重新安排您的预约。

Your healthcare provider may recommend up to an additional 11 monthly doses..

您的医疗保健提供者可能会建议每月增加11剂。。

JELMYTO is given to your kidney through a tube called a catheter.

杰尔米托是通过一种叫做导管的管子给你的肾脏的。

During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

在使用杰米托治疗期间，您的医疗保健提供者可能会告诉您服用其他药物或改变您目前服用药物的方式。

After receiving JELMYTO:

收到JELMYTO后：

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.

杰尔米托可能会导致你的尿液颜色从紫色变为蓝色。避免皮肤和尿液接触至少6小时。

To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.

要小便，男性和女性应该坐在马桶上，用完后冲洗几次。上完卫生间后，用肥皂和水好好洗手、大腿内侧和生殖器部位。

Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

与尿液接触的衣物应立即清洗，并与其他衣物分开清洗。

JELMYTO may cause serious side effects, including:

杰尔米托可能会引起严重的副作用，包括：

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain.

将尿液从肾脏输送到膀胱的管子肿胀和变窄（输尿管梗阻）。如果您出现肿胀和狭窄，并且为了保护肾脏免受损害，您的医疗保健提供者可能会建议在输尿管中放置一个小塑料管（支架），以帮助肾脏引流。

Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO..

如果您在使用杰米托治疗期间出现侧面疼痛或发烧，请立即告知您的医疗保健提供者。。

Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO..

骨髓问题。JELMYTO会影响你的骨髓，并会导致你的白细胞、红细胞和血小板计数下降。您的医疗保健提供者将在每次治疗前进行血液检查，以检查您在使用杰米托治疗期间的血细胞计数。如果您在使用JELMYTO治疗期间出现骨髓问题，您的医疗保健提供者可能需要暂时或永久停止JELMYTO。。

The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

杰米托最常见的副作用包括：尿路感染、尿中有血、副作用、恶心、排尿困难、肾脏问题、呕吐、疲倦、胃（腹部）疼痛。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

鼓励您向FDA报告处方药的负面副作用。访问www.fda.gov/medwatch或致电1-800-fda-1088。您也可以致电1-855-987-6436向UroGen Pharma报告副作用。

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

有关更多信息，请参阅JELMYTO完整的处方信息，包括患者信息。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the anticipated submission of an NDA to the FDA for UGN-102 and the timing thereof; the anticipated timing for an FDA decision; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs; and the potential of UroGen’s sustained release technology to make local delivery more effective as compared to other treatment options.

本新闻稿包含1995年《私人证券诉讼改革法案》中定义的前瞻性声明，包括但不限于以下声明：预期向FDA提交UGN-102保密协议及其时间；FDA决定的预期时间；UroGen专有RTGel技术改善现有药物治疗效果的潜力；与其他治疗方案相比，尿激素缓释技术使局部分娩更有效的潜力。

Words such as “anticipate,” “assume,” “could,” “plan,” “potential,” “will,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary results may not be indicative of results that may be observed in the future; the timing and success of clinical trials and potential safety and other complications thereof; unforeseen delays that may impact the timing of progressing clinical trials and reporting data; findings from the durability of response endpoint from the ENVISION Phase 3 study may not be positive, and in such event, UroGen’s NDA pathway could be negatively impacted; even if the durability of response endpoint data from the ENVISION Phase 3 study are positive, there is no guarantee that the current clinical development plan for UGN-102 will ultimately support submission of an NDA; even if an NDA for UGN-102 is accepted by the FDA, there is no guarantee that such NDA will be sufficient to support approval of UGN-102 on the timeframe expected, or at all; the ability to obtain regulatory approval within the timeframe expected, or at all; the ab.

诸如“预期”、“假设”、“可能”、“计划”、“潜力”、“意愿”等词语，或其他表达未来事件或结果不确定性的词语，以识别这些前瞻性陈述。这些声明受到许多风险、不确定性和假设的影响，包括但不限于：初步结果可能并不表明未来可能观察到的结果；临床试验的时机和成功以及潜在的安全性和其他并发症；可能影响临床试验和报告数据进展时间的不可预见的延迟；ENVISION 3期研究的反应终点的持久性结果可能不是积极的，在这种情况下，尿原的NDA途径可能会受到负面影响；即使ENVISION第3阶段研究的反应终点数据的持久性是积极的，也不能保证UGN-102的当前临床开发计划最终会支持NDA的提交；即使UGN-102的NDA被FDA接受，也不能保证该NDA足以支持UGN-102在预期的时间范围内或根本不支持UGN-102的批准；在预期时间内或根本无法获得监管部门批准的能力；ab。