以色列特拉维夫/北卡罗来纳州罗利 – RedHill Biopharma Ltd. (纳斯达克：RDHL) (特拉维夫股票交易所：RDHL) (“RedHill”或“公司”) 是一家专业生物制药公司，主要专注于开发并销售胃肠疾病和炎症性疾病及癌症治疗方面的处于后期临床试验阶段的专有口服小分子药物。本公司今天披露了截至2017 年6月30日的第二季度财务结果。
截至2017年第二季度末，RedHill资产负债表上现金[1]达到$5100万，零债务。
[1] 包括现金及短期投资部分近期里程碑包括：
• RedHill专注于胃肠的两款特殊产品Donnatal®和EnteraGam®在美国开始推广活动之后，6月12日至30日期间实现初步净收入约$50万元
• 24毫克BEKINDA® (RHB-102)急性胃肠炎和慢性胃炎三期GUARD试验取得积极结果
• 启动TALICIA™ (RHB-105) 幽门螺杆菌感染验证性三期试验
• 12毫克BEKINDA®腹泻型肠易激综合征二期试验最后一名患者出组
• 胆管癌药物YELIVA® (ABC294640)获得孤儿药认证
2017年下半年预计将实现的潜在里程碑：
• RHB-104克罗恩病首个三期试验第二次独立数据安全监测委员会会议，包括中期疗效分析，以及评估因为成功的惊人效果提前结束试验的方案。数据安全监测委员会建议预计将在2017年8月初发布
• 12毫克BEKINDA®腹泻型肠易激综合征结果预计将在2017年9月发布
• 预计将在2017年10月举行有关成功的24毫克BEKINDA 三期GUARD试验的B类美国食品药品监督管理局会议
• 启动YELIVA®胆管癌、头颈癌黏膜炎和溃疡性结肠炎多个一B和二期试验，以及MESUPRON胰腺癌试验
• 预计将在2017年10月重新向美国食品药品监督管理局提交RIZAPORT®的新药申请
RedHill首席执行官Micha Ben Chorin说道：“我们对第二季度期间实现的重要里程碑感到满意，包括24毫克BEKINDA®急性胃肠炎三期GUARD试验取得积极结果，启动TALICIA™幽门螺杆菌感染验证性三期试验，专注于胃肠道的销售团队启动Donnatal®和EnteraGam®在美国的推广活动并单单在6月下半月便取得了令人鼓舞的约$50万初步净收入。截至第二季度末现金头寸$5100万，使我们能够继续执行战略计划，积极推进后期临床项目，以及进一步收购在美国的商业胃肠产品。”
电话会议和网络播放信息：
公司周二（2017年7月25日）召开电话会议来查看财务结果和业务亮点。可以在公司网站http://ir.redhillbio.com/events.cfm重听电话会议，重听有效期30天。
RedHill Biopharma Ltd介绍：
RedHill Biopharma Ltd (纳斯达克：RDHL) (特拉维夫股票交易所：RDHL)是一家总部位于以色列的专业生物医药公司，主要专注于开发并销售治疗肠胃疾病和炎症性疾病以及癌症方面的处于后期临床试验阶段的专有口服小分子药。 RedHill在美国推广两款胃肠产品——治疗肠易激综合征和急性小肠结肠炎的口服处方辅助药物Donnatal®，以及用于医生监督下慢性腹泻和稀便饮食管理的医疗食品EnteraGam®。 RedHill目前处于临床阶段的产品管线包括： (i) TALICIATM (RHB-105) -治疗幽门螺杆菌感染的口服混合药，首个三期试验获得成功，正在进行验证性三期试验；(ii) RHB -104 -治疗克罗恩病的口服混合药，正在进行首项三期试验，已经完成治疗多发性硬化症的IIa期试验并获得非结核性分枝杆菌感染的合格感染疾病产品资格；(iii )BEKINDA@ (RHB-102) -日服一次的昂丹司琼口服药片制剂，急性肠胃炎和胃炎三期试验取得成功结果，正在进行治疗腹泻型肠易激综合征的二期试验；(iv ) RHB-106 -肠道准备药物胶囊，已经授权给Salix Pharmaceuticals Ltd.；(v) YELIVA@ (ABC294640) -二期阶段的口服SK2选择性抑制剂，是首创新药，靶向为多种肿瘤、炎症性和胃肠道适应症； (vi) MESUPRON -处于二期试验阶段的口服蛋白酶抑制剂，是首创新药，靶向为胃肠和其他实体瘤；(vii) RIZAPORT@ (RHB-103) -利扎曲坦口薄膜制剂，治疗急性偏头痛，正在与美国食品药品监督管理局讨论新药申请，通过欧洲分散审批程序在两个欧盟国家获得上市许可。欲了解与本公司有关的更多资讯，请访问：www.redhillbio.com。
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal® and EnteraGam®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) the Company’s Expanded Access Program, which allows patients with life-threatening diseases potential access, subject to regulatory and other approvals, to RedHill’s investigational new drugs that have not yet received regulatory marketing approval, if a patient suffers an adverse experience using such investigative drug, potentially adversely affecting the clinical development program of that investigational product or the Company generally; (xiv) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
注：该新闻稿的唯一官方版本是本公司发布的英文原版稿件。本摘要和翻译版本仅为方便阅读之目的。
公司联络人
Adi Frish
业务发展和许可高级副总裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投资者关系联络人 （美国）
Marcy Nanus
高级副总裁
The Trout Group
+1-646-378-2927
[email protected]
