NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced the appointment of William “Bill” Conkling as Chief Commercial Officer. He brings more than two decades of experience developing and commercializing novel cancer and rare disease therapeutics to Protara. “It is a pleasure to welcome Bill, a deeply experienced and proven commercial leader,” said Jesse ...

纪要涉及的公司和行业 - 公司：Protara Therapeutics - 行业：生物科技、肿瘤治疗 纪要提到的核心观点和论据 产品TARA 002介绍 - **产品特性**：是一种经过基因改造的化脓性链球菌菌株，通过专有制造工艺灭活，保留免疫刺激特性，源于OK432主细胞库，拥有除日本和台湾外的全球权利 [3][4] - **与BCG的异同**：相同点为都是细菌免疫增强剂，驱动Th1促炎反应，偏好M1极化；不同点在于TARA 002是TLR2激动剂，BCG是TLR4激动剂，TARA 002体外实验显示更强的肿瘤细胞杀伤能力、更高的关键促炎细胞因子和趋化因子上调以及IL - 8下调，动物实验有70%的小鼠60天无癌 [5][6][7] 疗效预期 - **BCG无反应患者**：预计年底分享25名BCG无反应、6个月可评估患者的数据，12个月时CR达到30%可进入市场竞争，40%有竞争力，50%为同类最佳，公司目标是40 - 50% [11][12][13] - **BCG初治患者**：6个月CR率63%，12个月43%，任何时间CR率76%，有50%为伴发乳头状瘤患者，数据令人鼓舞，有望成为BCG的替代方案 [41] 再诱导治疗 - 所有免疫增强药物都有再诱导的能力，关键是完全缓解这一终点，有残留CIS的患者再诱导后可在6个月转化为完全缓解 [14][15][17] 患者招募 - 招募进展顺利，2024年初制定策略解决美国和国际的监管问题，目前美国有30个站点，日本获批，中国IND被接受，南美国家站点开放，目标是2026年春季完成招募 [19] - 患者类型：研究将与其他研究一致，倾向于CIS单一人群，预计CIS患者占比约75%，伴发乳头状瘤患者占比约25% [21][23] 市场机会 - 患者为避免膀胱切除术会尝试多种治疗方案，市场有多种治疗方式和机制，未来会讨论药物的排序问题，强生认为该市场规模约50亿美元 [25][26] - 复发患者：约50%的患者12个月无病，另外50%可作为潜在治疗人群，市场患者数量大，可能因新药避免膀胱切除术而增长 [32][33][35] 竞争优势 - 疗效：预计与现有药物相当或更好，耐久性与其他免疫增强药物一致 - 耐受性：药物耐受性好，医生愿意给体弱老年患者使用 - 易用性：使用方便，有利于医生快速采用和患者偏好 [36][37][38] 长期发展计划 - 与FDA沟通：在BCG初治患者中数据良好，计划今年第三季度与FDA沟通注册研究，希望以化疗为对照 [41][43][44] 即将到来的催化剂和更新 - 年底：BCG无反应患者25名6个月可评估数据；胆碱注册2b/3期研究首剂确认队列数据；LMs研究数据更新 [50][51] 其他重要但是可能被忽略的内容 - 公司在LMs项目中等待名单已满，正在积极给药，扩展队列正在招募，数据积极 [51] - 公司进行了一项与美国三大支付方之一的大型真实世界数据库分析，发现CIS诊断患者中接受BCG和化疗产品的人数相近 [44]

Protara Therapeutics (TARA) FY 2025 Conference May 20, 2025 12:30 PM ET Speaker0 Great. I'd like to welcome back everybody to H. C. Wainwright's BioConnect Conference at Nasdaq. My name is Andres Maldonado. I'm a biotech analyst here at the firm, and it's my pleasure to welcome Protara Therapeutics next. And from the company, we have CEO, Jesse Schefferman. Welcome, Jesse. Speaker1 Thanks, Andres. Speaker0 Yeah. Really a pleasure to have you here, and always enjoy speaking with you about the landscape. So l ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36694 10010 (Zip Code) (646) 844-0337 (Registrant's telephone number, including area code) Securities registered pursuant to Sect ...

Exhibit 99.1 Protara Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update NEW YORK, May 8, 2025 – Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced financial results for the first quarter ended March 31, 2025, and provided a business update. "We have made significant progress thus far in 2025, notably with the recent presentation of positive interim results ...

Reported positive interim results demonstrating durable responses in the ongoing Phase 2 ADVANCED-2 trial of TARA-002 in NMIBC Results from planned interim analysis of approximately 25 six-month evaluable BCG-Unresponsive patients expected by the end of 2025 Dosing of first patient in THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on parenteral support expected in Q3 2025Strengthened leadership team with key appointments of Leonardo Viana Nicacio, M.D., as Chief Medical Officer, ...

Interim Data Presentation from the American Urological Association Annual Meeting April 2025 Forward Looking Statements Statements contained in this presentation regarding matters that are not historical facts are "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "designed," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," ...

NEW YORK, May 01, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA) (“Protara” or the “Company”), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced the recent grants of inducement non-qualified stock options and restricted stock units (RSUs) to six newly-hired employees. The independent members of Protara’s Board of Directors approved the award from the Company's 2020 Inducement Plan, as amended (the “Inducement Plan” ...

纪要涉及的公司和行业 - 公司：Protara Therapeutics（TARA） - 行业：生物医药行业，专注于非肌肉浸润性膀胱癌（NMIBC）治疗药物研发 纪要提到的核心观点和论据 产品优势 - **独特免疫激活机制**：TAR - two不仅能激活其他获批或实验性免疫疗法激活的特定细胞因子，还能激活更广泛的免疫谱，为持久抗肿瘤反应提供生物学基础[9]。 - **良好安全性和耐受性**：多数不良事件为1级且短暂，无3级或更高级别的治疗相关不良事件，无患者因不良事件停药，常见不良事件与细菌免疫增强的典型反应一致[16]。 - **使用便捷**：通过导管进行两次15分钟的简单给药，无需特殊处理要求，护士和使用者无需改变行为，与卡介苗（BCG）相比更易被接受[7][32]。 - **临床数据支持**：在ADVANCE - two临床试验中，TAR - two在BCG无反应和BCG初治患者队列中均显示出良好的完全缓解（CR）率和持久反应[7][12][15]。 临床数据 - **BCG无反应队列**：截至2025年4月16日数据截止，5例关键患者中，TAR - two在任何时间的CR率为100%，6个月时为100%，9个月时为80%，12个月时为67%。目前有17例患者入组，包括12例尚未达到3个月首次疗效评估的患者以及正在筛选的患者[12]。 - **BCG初治队列**：21例可评估患者中，TAR - two在任何时间的CR率为76%，6个月和9个月时均为63%，12个月时为43%。超过80%的患者在6至9个月维持完全缓解，100%的患者在9至12个月维持CR[15]。 未来规划 - **持续推进临床试验**：计划在BCG无反应队列年底进行下一次数据更新，有望在2025年底获得25例BCG无反应患者的6个月结果；预计今年晚些时候分享BCG初治患者群体注册路径的反馈[13][19]。 - **探索新治疗方案**：完成了系统给药的非临床工作，计划今年晚些时候启动两个额外队列（C和D）的试验；今年晚些时候将宣布联合治疗工作，且与已获批或临床研究中的药物无重叠毒性[46][47]。 其他重要但是可能被忽略的内容 - **患者招募情况**：美国学术中心的IRB和癌症委员会审批时间长的问题得到解决，推动了患者招募；全球扩张至拉丁美洲和亚洲国家，增加了患者来源[25][26][27]。 - **患者基线特征**：BCG无反应队列中有患者经过多种治疗失败，包括BCG、Jemdosi、pembrolizumab和最近获批的NMIDC单药治疗；BCG初治队列中多数患者有化疗史，很少有首次诊断的BCG初治患者[39][42]。 - **再诱导治疗情况**：再诱导治疗后患者能进入缓解状态并保持持久反应，多数患者在3个月时因残留CIS需要再诱导，再诱导为额外的三次给药，所有接受再诱导的患者至少有肿瘤视觉消退[53][62][63]。 - **与竞争对手比较**：不同注册研究在时间点、活检要求、患者定义等方面差异大，直接比较困难；预计随着纳入更多伴发乳头状瘤患者，TAR - two的反应率可能下降，但仍有竞争力[67][69]。 - **对Pfizer研究的看法**：仍在消化Pfizer的CREST研究数据，若ICI + BCG在初治患者中获批，可能成为FDA在考虑TAR - two初治研究时的合理对照[79][80]。

TARA-002 demonstrates 100% complete response rate at any time and 67% 12-month landmark complete response rate in BCG-Unresponsive patientsTARA-002 demonstrates 76% complete response rate at any time and 43% 12-month landmark complete response rate in BCG-Naïve patientsFavorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse eventsOn track to present updated interim data from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025Company to hos ...