Choline bitartrate

✦ ✦ ✦ 随着中国经济的快速增长和科技实力的提升，国内新药研发蓬勃发展，为出海打下良好基础。一直以来，中国医药、原料药出口贸易在东南亚市场占有举足轻重的份额。其中，印度尼西亚、泰国、越南、菲律宾和马来西亚五个国家占据了东南亚医药市场的90%以上。未来这些国家将会成为国内企业转战的重要市场，包括投资建厂等深度合作开发。 为助力中国药企加速布局东南亚医药市场，9月11日，东南亚医药市场开拓机遇与挑战主题会议将于CPHI & PMEC 制药工业展（深圳）展会期间在深圳会展中心（福田）举办。会议将从当下市场的最新国际形势出发，结合案例与报告，与上下游企业共同探讨东南亚市场的发展机遇。 ✦ ✦ ✦ 东南亚医药市场开拓机遇与挑战主题会议 会议时间 9月11日 会议地点 深圳会展中心（福田） 论坛区A（展位：9A56） 主办单位 上海博华国际展览有限公司 承办单位 北京东方比特科技有限公司 协办单位 E药经理人 扫描太阳码 0元领票并报名听会 8月30日前完成预登记 现场可领取电子会刊一份 SHENZHEN 会议议程 09:30 主持人致辞 09:40-10:20  东南亚国家医药国际贸易报告 嘉宾介绍 吴惠芳 北京东方比特（健康网）总经理兼首席研究员，北京玉德未来控股有限公司副总裁 吴女士在军事医学科学院药物分析专业获理学硕士学位，1980年起从事药学相关工作，2000年前在部队医疗、科研机构从事临床药学、科研管理等工作，技术职务副主任药师。2000年退役后从事医药信息研究工作，专注于医药行业研究、市场研究、产业链结构研究等领域。在医药原料药、医药商品进出口、医药产业数据等信息方面有发布了大量文献资料和报告发表。为国内外企业、政府和科研机构提供咨询服务。连续多年为“中国化学制药工业协会”所著《医药发展蓝皮书》、《中国医药手册》作者之一；是《中国医药报》、《医药经济报》的特约撰稿人，在国内重要医药报刊发表大量文章。多次被邀请在中国医药行业大型会议和展览上做有关中国医药市场专题演讲。她的演讲以实际数据和案例阐明问题、总结变化规律，在中国制药企业中广为流传，受到医药界的好评。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 10:20-10:50  中国制药企业出海东南亚国家的案例分享 嘉宾介绍 王亚锋 上海医药国际业务事业部东南亚区域负责人、上药泰国总经理 中国药科大学本科，中欧国际工商学院Global EMBA。 从事医药国际营销工作十余年，深厚的医药行业知识和专业能力。拥有丰富的海外子公司运营和营销团队管理经验。深度参与海外工厂立项，写字楼，仓库等绿地项目建设。 海外常驻包括非洲加纳，尼日利亚，乌干达，科特迪瓦，东南亚泰国，菲律宾等多个国家。熟悉多个市场药政法规以及行业准入要求。多次在海外国家从零开始设立全资公司、合资公司，组建销售团队，实现业绩从零突破，运作药品进入国家用药指南和国家医保。所在团队曾实现单品种中国制剂出口第一。 历任复星医药集团桂林南药国际商务代表，销售经理，海外国家经理，大区经理等，现任上海医药国际业务事业部东南亚区域负责人，上药泰国总经理。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 10:50-11:20  印度尼西亚制药业的机遇和市场开拓实践 嘉宾介绍 张君丽 成都市一诺医药化工有限公司总经理采购总监 公司团队深耕印尼市场十年，专注医药API等产品出口； 聘请多名印尼本地员工，长期穿梭在印尼各个制剂工厂，拜访客户，与当地前十大药企均有超级深度的合作与链接！ 11:20-11:45  印尼清真医药产品市场情况更新 嘉宾介绍 Dr. Ir. Muslich, M.Si Halal Partnership  and Audit Services Director, LPPOM 获得IPB大学学士(S1)、研究生(S2)和博士(S3)学位;此前曾在多家私营公司工作(1991年至1993年)，PT TELKOM WITEL IX Jayapura农业和农用工业发展中心经理(1993年至1994年)，LPPOM MUI清真保证体系负责人(2010年至2015年)，QA和LPPOM MUI标准负责人(2015年至2019年)，LPPOM MUI高级顾问(2020年)，MUI清真认证要求开发团队负责人(2010年至2011年);现为IPB大学农业技术学院农业工业工程系讲师(自1994年起)，清真审核员(自1995年起)，清真管理体系标准制定技术委员会(SNI 99 001)成员，清真家禽屠宰场(SNI 99 002)，家庭切清真反刍(SNI 99 003)，清真食品(SNI 99 004)国家标准化机构(自2015年起)，SKKNI主管能力测试设备开发团队负责人Halal & SKKNI清真审核员(自2017年起)，国家认证机构能力评估员职业(BNSP)(自2015年起)，食品安全能力评估员，机构专业认证(LSP)食品质量保证与安全(JMKP)(自2015年起);于2020-2022年被任命为LPPOM MUI清真合作与审计服务总监。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 11:20-12:00  圆桌讨论：寻找东南亚市场的机会 讨论嘉宾 深圳市远邦医药有限公司 湖南尔康制药股份有限公司 成都倍特药业有限公司 广州康臣药业有限公司 ...... 扫描太阳码 0元领票并报名听会 8月30日前完成预登记 现场可领取电子会刊一份 把握东南亚市场发展机遇 加速融入全球制药供应链 随着东南亚医药市场的发展潜能进一步释放，中国医药企业将迎来更多发展机遇。作为中国药企链接国际市场的重要纽带，CPHI & PMEC 制药工业展（深圳）将携手400余家优质展商，共同探索企业在东南亚乃至全球市场的发展路径。 下面就请跟随小编的步伐，一起走近本期的优选展商吧！ 浙江瑞邦药业股份有限公司 展位：9F08 浙江瑞邦药业股份有限公司成立于1956年，具有60多年生产医药原料药和食品添加剂的生产经验。公司以药品生产质量管理规范（GMP) 标准组织生产和销售。本公司的产品获得了美国FDA，欧洲CEP和中国GMP的认证。主要产品有葡萄糖酸盐系列，莫匹罗星，莫匹罗星钙，环孢菌素，夫西地酸等。浙江瑞邦药业股份有限公司在国内外都享有良好的声誉。产品远销美国，欧洲，日本，印度及其他南美和东南亚地区。 主推产品 环孢菌素、莫匹罗星、莫匹罗星钙、葡萄糖酸钙、葡萄糖酸锌、葡萄糖酸钾、葡萄糖酸镁、葡萄糖酸亚铁、葡萄糖酸铜、葡萄糖酸锰、葡萄糖酸钠、多粘菌素B、夫西地酸、夫西地酸钠、米尔贝肟、葡萄糖酸内酯、非达霉素、甘草次酸、原儿茶酸。 ☝🏿☝🏿上下滑动查看完整展商介绍 河北华晨药业集团有限公司 展位：9D46 河北华晨药业集团有限公司，始建于1991年，坐落于黄骅经济开发区。是一家集研发、生产、销售药用包装材料、原料药、制剂、医疗器械，开展国内外贸易为一体的医药企业。集团公司现下设河北华晨药业有限公司、黄骅华宾生物科技有限公司、河北华迪药业有限公司、华晨吉海（北京）药物研究院。目前华晨药业拥有通过GMP认证的药用氯化钠、碳酸氢钠、氯化钾及新增制剂包括片剂、硬胶囊制剂、颗粒剂、散剂、软膏剂、凝胶贴膏剂、口服液等数十种，同时生产药用PE袋、膜、包装桶、瓶等药用包装材料等。 主推产品 氯化钠、碳酸氢钠、氯化钾、氯化钙、氯化铵、依地酸二钠、重酒石酸胆碱、富马酸（辅料、富马酸亚铁、醋酸钙、醋酸钠、硫酸镁、碘化钾、氯化镁、富马酸亚铁、葡萄糖酸锌、葡萄糖二酸钙、双乙酸钠、树脂再生剂、碳酸镧、硫酸钾、利多卡因、氟比洛芬、氯化镁、麝香草粉、盐酸利多卡因、葡萄糖酸钙、洛索洛芬钠、磷酸奥司他韦、无水硫酸钠、氨苯蝶啶、托匹司特、硫酸亚铁、西甲硅油、硫酸双肼屈嗪、甘羟鋁、葡萄糖酸亚铁、叔丁醇镁、异丙醇镁、二甲硅油、碳酸钙、亚硫酸镁（六水）、硫酸钾、乳酸钙、乳酸钠、乳果糖、丙胺卡因、喷托维林、丁卡因、双氯芬酸依泊胺、克立硼罗、阿达帕林、盐酸异丙嗪、高岭土、克罗米通、盐酸异丙嗪、氨苯蝶啶、叔丁醇镁、异丙醇镁、亚硫酸镁知名。 ☝🏿☝🏿上下滑动查看完整展商介绍 山西阳和药业有限公司 展位号：9A13 山西阳和药业有限公司成立于2017年，坐落于山西省大同市阳高县龙泉工业园区。公司注册资本5100万元，总占地面积100亩。阳和药业作为化学原料药的商业化生产基地，专业从事特色化学原料药的研发、生产、销售。公司现拥有多条原料药生产线，产品涉及呼吸系统、消化系统等多个领域。目前公司可大批量生产乙酰半胱氨酸、间苯三酚、间苯三酚三甲醚、聚乙烯醇等原料药。 主推产品 乙酰半胱氨酸、间苯三酚、聚乙烯醇、间苯三酚三甲醚。 ☝🏿☝🏿上下滑动查看完整展商介绍 浙江荣耀生物科技股份有限公司 展位：9C51 浙江荣耀生物科技股份有限公司创立于1999年，位于台州湾经济技术开发区，是一家集研发、生产、销售于一体的创新型医药企业，是国家高新技术企业、浙江省专精特新中小企业、浙江省科技型中小企业。业务涵盖医药原料药及中间体、兽药原料药及中间体、CDMO等。 主推产品 二硝托胺148-01-6、甲砜霉素15318-45-3、氟苯尼考73231-34-2、非班太尔58306-30-2、芬苯达唑43210-67-9、莫昔克丁113507-06-5、赛拉菌素220119-17-5、氟雷拉纳864731-61-3、奥拉替尼1208319-26-9、2-氨基-N-(2、2、2-三氟乙基)乙酰胺盐酸盐1171331-39-7、三氯苯达唑68786-66-3、癸氧喹酯18507-89-6、尼卡巴嗪330-95-0、3′、5′-二氯-2、2、2-三氟苯乙酮130336-16-2、4-氯吡咯并嘧啶3680-69-1、反式-N-甲基-[4-(甲氨基)环己基]甲磺酰胺1809995-95-6、依帕司他82159-09-9、盐酸氨溴索23828-92-4、盐酸金刚乙胺1501-84-4、盐酸溴己新611-75-6、西司他丁82009-34-5、3-甲基-6-硝基-1H-吲唑6494-19-5、2-[4-(2-吡啶基)苄基]-肼羧酸叔丁酯198904-85-7、2-氨基-1-(2、5-二甲氧基苯基)乙醇3600-87-1、3-(三氟甲基)-5、6、7、8-四氢-[1、2、4]三唑并[4、3-a]吡嗪盐酸盐762240-92-6、(3S、4R)-4-(4-氟苯基)-1-甲基-3-哌啶甲醇105812-81-5、1-(4-氨基苯基)环戊甲腈115279-73-7、3-氨基-1-金刚烷醇702-82-9、1-金刚烷甲酸828-51-3、2-金刚烷酮700-58-3、1-金刚烷胺768-94-5、1-金刚烷甲醇770-71-8、2-金刚烷醇700-57-2、1-金刚烷醇768-95-6。 ☝🏿☝🏿上下滑动查看完整展商介绍 江苏宇田医药有限公司 展位：9E31 江苏宇田医药有限公司是一家从事现代医药研发、生产、销售为一体的新型特色API及CDMO制药企业，致力于为国内各大制药企业提供高质量的原料药与中间体，公司产品同时远销欧洲、日韩、印度等数十个国家，为国家重点高新技术企业、市科技小巨人企业、中华药港新医药产业基地骨干企业之一。 宇田医药始终把科研开发作为企业可持续发展的支撑力量，是国内科研投入较多的药企之一，公司以连云港研发中心为科研载体，配合杭州科巢生物科技、连云港万科生物科技、黑龙江迪诺医药，自主创新能力不断增强。形成了“以一带三”的良性格局。宇田医药在江苏连云港、黑龙江佳木斯建有两个生产基地，获得国家高新技术企业、省级工程技术研究中心、江苏省瞪羚企业、江苏省科技型中小企业、安全标准化二级企业、省两化融合示范试点企业，同时也获得了原料药品种的GMP和注册现场核查的二合一认证，先后承担省/市级成果转换等多个省/市级科技项目；获得授权专利与商标数十项；通过ISO9000、ISO14000认证。这些荣誉的取得标志着企业药品生产质量和管理水平走在了全国医药行业前列。 主推产品 原料药：碘克沙醇、碘海醇、阿托伐他汀钙、瑞舒伐他汀钙、盐酸伊伐布雷定、利奈唑胺、西洛多辛、盐酸厄洛替尼、盐酸莫西沙星及各中间体。 中间体：造影剂系列中间体、多尼培南侧链、比阿培南侧链、1,4-丁二磺酸。 ☝🏿☝🏿上下滑动查看完整展商介绍 江苏同禾药业有限公司 展位：9D26 江苏同禾药业有限公司是江苏万兴创业投资有限公司的全资子公司，是一家集制剂药、原料药和保健食品的研发、生产、销售为一体的国家高新技术企业。连续8年，跻身于常熟市百强企业前50 名。 公司拥有原料药、片剂、胶囊剂和颗粒剂的GMP证书。硫辛酸、6.8-二氯辛酸乙酯、右旋硫辛酸钠、环丙贝特、10-甲氧基亚氨基芪等多个产品被评为江苏省高新技术产品；硫辛酸、盐酸二甲双胍等取得了原料药品批件，厄多司坦片、氨酚伪麻分散片和新雪胶囊等取得药品注册批件和新药证书；硫辛酸片和胶囊即将取得新药证书，另有10多个新药正在SFDA审批中。调节血糖和控制并发症的保健食品唐苹片正在全国热销中。 主推产品 硫辛酸系列、右旋硫辛酸、右旋硫辛酸钠盐、右旋硫辛酸氨基丁三醇盐。 ☝🏿☝🏿上下滑动查看完整展商介绍 CPHI & PMEC 制药工业展（深圳）致力于打造国际化制药产业生态圈，汇集产业链上下游实力企业，以技术驱动产业提升，助推更多中国药企扬帆“出海”，聚势共赢！ 扫描二维码 0元领票 8月30日前完成预登记 现场可领取电子会刊一份 金秋九月·不见不散！ 联系我们 参观咨询 林女士 电话：021-33392105 邮箱：ashley.lin@imsinoexpo.com 张女士 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On track to report preliminary data from six-month evaluable patients in ADVANCED-2 trial of TARA-002 in NMIBC in Q4 2024 Expect to dose first patient in pivotal trial for IV Choline Chloride in Q1 2025 Current cash resources are approximately $90 million, including net proceeds from April 2024 private placement, expected to fund operations into 2026 NEW YORK, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today provided a business update and announced financial results for the second quarter ended June 30, 2024. “The first half of the year has been marked by significant progress as we advance our mission to deliver transformative therapies to patients with cancer and rare diseases,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “Notably, we were pleased with our recent announcement of positive three-month data from our TARA-002 program in patients with non-muscle invasive bladder cancer (NMIBC). We believe our growing clinical dataset continues to support the potential of TARA-002 to serve as a meaningful addition to the NMIBC treatment landscape and look forward to sharing interim data from our ADVANCED-2 trial in the fourth quarter of this year. We also continue to focus on identifying the best agent for combination as we believe TARA-002’s mechanism of action and safety profile give it strong potential for use in combination therapy in NMIBC.” Mr. Shefferman continued, “Beyond the NMIBC program, we announced alignment with the FDA on a path forward for intravenous (IV) Choline Chloride for patients on long-term parenteral nutrition (PN), and we expect to start dosing patients in our pivotal trial in the first quarter of 2025. Finally, enrollment continues in our Phase 2 STARBORN-1 trial of TARA-002 in pediatric patients with lymphatic malformations (LMs), an underserved population with no U.S. Food and Drug Administration (FDA)-approved therapies.” Recent Progress and Highlights TARA-002 in NMIBC The Company expects to share preliminary results from a pre-planned risk-benefit analysis from approximately ten 6-month evaluable patients in the ongoing Phase 2 open-label ADVANCED-2 trial in the fourth quarter of 2024. The ADVANCED-2 trial is assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-unresponsive (n≈100) and BCG-Naïve (n=27). The BCG-Unresponsive cohort has been designed to be registrational aligned with the FDA’s 2018 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry. In addition to the ADVANCED-2 trial, the Company is assessing higher dosing at an 80KE1 dose and has completed enrollment of a three-patient exploratory dosing cohort with data expected by the end of this year. To date, no differences in safety profile have been observed between the 40KE and the 80KE doses. The Company continues to explore systemic priming dosing prior to initiation of intravesical administration, as well as combination therapy with TARA-002 in NMIBC patients with CIS. Given TARA-002’s mechanism of action and safety profile, the Company believes it has strong potential for use in combination therapy and is working to determine the best possible options for the clinical program. IV Choline Chloride for Patients on PN In April 2024, the Company announced alignment with the FDA on a registrational path forward for IV Choline Chloride in patients dependent on PN who are or may become unable to synthesize choline from oral or enteral nutrition sources. The Company expects to begin dosing patients in a pivotal trial in the first quarter of 2025. TARA-002 in LMs Dosing continues to progress in the ongoing STARBORN-1 trial. The Company has completed enrollment of the first safety cohort and will soon begin enrolling patients in the second safety cohort. STARBORN-1 is a Phase 2 clinical trial of TARA-002 in pediatric patients with macrocystic and mixedcystic LMs. Including an age de-escalation safety lead-in, the trial will enroll approximately 30 patients who will receive up to four injections of TARA-002 spaced approximately six weeks apart. The primary endpoint of the trial is the proportion of participants with macrocystic and mixed cystic LMs who demonstrate clinical success, defined as having either a complete response (90% to 100% reduction from baseline in total LM volume) or substantial response (60% to less than 90% reduction in total LM volume) as measured by axial imaging. In addition to LMs, the Company believes that TARA-002 has the potential to be used to treat other maxillofacial cysts. While completing the STARBORN-1 trial in LMs remains a priority, there may be potential in the future to explore the use of TARA-002 to treat different types of maxillofacial cysts based on the historical literature from the TARA-002 predecessor, OK-432, as well as data in a pediatric patient with a maxillofacial cyst called a Ranula, which resolved nearly 100% after a single 1KE dose of TARA-002. Corporate Update In June 2024, the Company appointed Lisa Schlesinger as Vice President, Head of New Product Development and Market Access. Second Quarter 2024 Financial Results As of June 30, 2024, cash, cash equivalents and investments in marketable debt securities totaled approximately $89.6 million, which includes approximately $42.0 million in net proceeds from the April 2024 private placement. The Company expects its cash, cash equivalents, and investments in marketable debt securities will be sufficient to fund its planned operations and data milestones into 2026. Research and development expenses for the second quarter of 2024 decreased to $6.4 million from $7.2 million for the prior year period. This decrease was primarily due to a decrease in non-clinical and clinical trial expenses related to TARA-002. General and administrative expenses for the second quarter of 2024 decreased to $4.3 million from $4.9 million for the prior year period. This decrease was primarily due to a reduction in personnel-related expenses associated with stock-based compensation as well as a decrease in market development activities. For the second quarter of 2024, Protara incurred a net loss of $9.5 million, or $0.45 per share, compared with a net loss of $11.3 million, or $1.00 per share, for the same period in 2023. Net loss for the second quarter of 2024 included approximately $1.1 million of stock-based compensation expenses. About TARA-002 TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil® in Japan by Chugai Pharmaceutical Co., Ltd and also approved in Taiwan. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response. About Non-Muscle Invasive Bladder Cancer (NMIBC) Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle. About Lymphatic Malformations (LMs) LMs are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of three years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels, lymphatics; recurrent infection, and cosmetic and other functional disabilities. About IV Choline Chloride IV Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy initially in development for patients receiving parenteral nutrition. Choline is a known important substrate for phospholipids that are critical for healthy liver function and also plays an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle function, and bone health. PN patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PN formulations containing choline. Approximately 80 percent of PN-dependent patients are choline-deficient and have some degree of liver damage, which can lead to hepatic failure. There are currently no available PN formulations containing choline. In the U.S. alone, there are approximately 40,000 patients on long-term parenteral nutrition who would benefit from an IV formulation of choline. IV Choline Chloride has the potential to become the first FDA approved IV choline formulation for PN patients. IV Choline Chloride has been granted Orphan Drug Designation by the FDA for the prevention of choline deficiency in PN patients. The Company was issued a U.S. patent claiming a choline composition with a term expiring in 2041. About Protara Therapeutics, Inc. Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com. References 1. Klinische Einheit, or KE, is a German term indicating a specified weight of dried cells in a vial. Forward-Looking Statements Statements contained in this press release 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,” “might,” “will,” “should” or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include but are not limited to, statements regarding Protara’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Protara’s business strategy, including its development plans for its product candidates and plans regarding the timing or outcome of existing or future clinical trials; statements related to expectations regarding interactions with the FDA; Protara’s financial position; statements regarding the anticipated safety or efficacy of Protara’s product candidates; and Protara’s outlook for the remainder of the year. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that contribute to the uncertain nature of the forward-looking statements include: risks that Protara’s financial guidance may not be as expected, as well as risks and uncertainties associated with: Protara’s development programs, including the initiation and completion of non-clinical studies and clinical trials and the timing of required filings with the FDA and other regulatory agencies; general market conditions; changes in the competitive landscape; changes in Protara’s strategic and commercial plans; Protara’s ability to obtain sufficient financing to fund its strategic plans and commercialization efforts; having to use cash in ways or on timing other than expected; the impact of market volatility on cash reserves; failure to attract and retain management and key personnel; the impact of general U.S. and foreign, economic, industry, market, regulatory, political or public health conditions; and the risks and uncertainties associated with Protara’s business and financial condition in general, including the risks and uncertainties described more fully under the caption “Risk Factors” and elsewhere in Protara's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Protara undertakes no obligation to update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as required by law. PROTARA THERAPEUTICS, INC. AND SUBSIDIARIESUnaudited Condensed Consolidated Balance Sheets(in thousands, except share and per share data) As of June 30,2024 December 31,2023 Assets Current assets: Cash and cash equivalents$89,581 $39,586 Marketable debt securities - 25,994 Prepaid expenses and other current assets 2,633 3,125 Total current assets 92,214 68,705 Restricted cash, non-current 745 745 Property and equipment, net 1,185 1,296 Operating lease right-of-use asset 4,768 5,264 Other assets 2,735 2,944 Total assets$101,647 $78,954 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$1,385 $2,434 Accrued expenses and other current liabilities 3,228 2,732 Operating lease liability 1,035 983 Total current liabilities 5,648 6,149 Operating lease liability, non-current 3,949 4,484 Total liabilities 9,597 10,633 Commitments and contingencies (Note 9) Stockholders’ Equity: Preferred stock, $0.001 par value, authorized 10,000,000 shares: Series 1 Convertible Preferred Stock, 8,028 shares authorized at June 30, 2024 and December 31, 2023, 7,991 shares issued and outstanding as of June 30, 2024 and December 31, 2023. - - Common stock, $0.001 par value, authorized 100,000,000 shares: Common stock, 20,629,772 and 11,364,903 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively. 21 11 Additional paid-in capital 313,021 268,725 Accumulated deficit (220,992) (200,384)Accumulated other comprehensive income (loss) - (31)Total stockholders’ equity 92,050 68,321 Total liabilities and stockholders’ equity$101,647 $78,954 PROTARA THERAPEUTICS, INC. AND SUBSIDIARIESUnaudited Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data) For the Three Months EndedJune 30, For the Six Months EndedJune 30, 2024 2023 2024 2023 Operating expenses: Research and development$6,387 $7,247 $14,135 $12,390 General and administrative 4,274 4,893 8,377 9,482 Total operating expenses 10,661 12,140 22,512 21,872 Loss from operations (10,661) (12,140) (22,512) (21,872)Other income (expense), net: Interest and investment income 1,148 846 1,904 1,533 Other income (expense), net 1,148 846 1,904 1,533 Net income (loss)$(9,513) $(11,294) $(20,608) $(20,339) Net income (loss) per share attributable to common stockholders, basic and diluted$(0.45) $(1.00) $(1.26) $(1.80)Weighted-average shares outstanding, basic and diluted 21,233,163 11,307,842 16,327,056 11,305,867 Other comprehensive income (loss): Net unrealized gain (loss) on marketable debt securities 1 133 31 352 Other comprehensive income (loss) 1 133 31 352 Comprehensive loss$(9,512) $(11,161) $(20,577) $(19,987) Company Contact: Justine O'MalleyProtara TherapeuticsJustine.OMalley@protaratx.com646-817-2836