RedHill Biopharma披露2017年第一季度财务结果

Redhill Biopharma Ltd NASDAQ:RDHL Pharmaceutical, Biotechnology,医药,生物科技
发布于: 5 月 4, 2017

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,致力于后期临床试验阶段胃肠疾病和炎症性疾病及癌症专有口服小分子药物的开发和商业化。本公司今天公布了截至2017年3月31日的第一季度财务结果。

2017年第一季度末RedHill资产负债表上负债为零,现金结余$6100万,使公司能够继续努力落实开发计划和美国商业化计划。

部分近期重要事件如下:

  • 商业胃肠药物Donnatal®美国市场独家联合推广协议
  • 商业胃肠产品EnteraGam®独家授权许可协议
  • 24毫克BEKINDA® (RHB-102)急性肠胃炎和慢性胃炎三期试验(GUARD试验)完成招募患者
  • 12毫克BEKINDA®腹泻型肠易激综合征二期试验完成招募患者
  • 启动RHB-104克罗恩病鸟型分枝杆菌副结核杆菌亚种(MAP)美国三期试验的非盲扩大试验
  • RHB-104获得美国食品药品监督管理局授予的合格抗感染疾病药品资格,治疗非结核分枝杆菌感染,享受快速审批待遇
  • YELIVA® (ABC294640)治疗胆管癌获得孤儿药认证

未来几个月预计将迎来的潜在重要事件:        

  • 24毫克BEKINDA® (RHB-102)急性肠胃炎和慢性胃炎三期试验(GUARD试验)预计将在2017年第二季度发布试验结果
  • 12毫克BEKINDA®腹泻型肠易激综合征二期试验预计将在2017年第三季度发布试验结果
  • 预计将在2017年第二季度启动RHB-105幽门螺杆菌感染炎症性三期试验
  • RHB-104克罗恩病MAP美国三期试验举行第二次独立数据和安全监测委员会会议,包括中期疗效分析,以及评估由于效果惊人在年中提前成功结束试验的方案
  • 预计将在2017年第二季度启动Donnatal®和EnteraGam®在美国的推广活动
  • 预计将在2017年下半年启动YELIVA® 治疗胆管癌、预防头颈癌粘膜炎和溃疡性结肠炎的一/二期试验
  • 预计2017年下半年启动MESUPRON 胰腺癌一/二期试验

RedHill首席财务官Micha Ben说道:“我们对2017年第一季度所取得的成绩感到满意,包括获得两款商业胃肠产品在美国市场的权利,这是RedHill在美国成为创造营收的专注胃肠药特殊医药公司战略计划的一部分,为我们可能获得批准的后期临床阶段研发线药品打下基础。截至第一季度末公司现金头寸$6100万元,使我们可以继续执行2017年战略计划,并努力推进后期阶段临床项目。我们十分期待未来几个月将发生的重要事件,包括BEKINDA®肠胃炎三期GUARD试验发布试验结果,启动RHB-105幽门螺杆菌感染验证性三期试验,正在进行的RHB-104克罗恩病MAP美国三期试验举行第二次独立数据和安全监测委员会会议,以及启动Donnatal®和EnteraGam®在美国的推广活动。”

电话会议和网络直播信息:

公司将在今天(2017年5月3日(周三)美国东部时间上午9:00)召开电话会议,回顾财务结果和业务亮点。

参与电话会议,请在电话会议开始前提前15分钟拨打:+1-877-280-2342(美国)、+1-212-444-0896(国际)、+972-3-763-0147(以色列)。会议代码:1922788

本次电话会议将在公司网站提供直播和重播,重听有效期30天。请至少提前15分钟登录公司网站http://ir.redhillbio.com/events.cfm进行注册,下载并安装必要音频软件。

RedHill Biopharma Ltd介绍:

RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家总部位于以色列的专业生物医药公司,主要专注于开发幷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已与Concordia就Donnatal®签署美国地区的联合推广协议,Donnatal®是一种用于治疗肠易激综合征和急性小肠结肠炎的处方口服辅助药物。RedHill目前处于临床阶段的产品管线包括:(i) 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;(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以及治疗多发性硬化症的IIa期概念验证试验;(iii)BEKINDA™ (RHB-102) -日服一次的昂丹司琼口服药片制剂,正在美国进行治疗急性肠胃炎和慢性胃炎的三期试验,以及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) -利扎曲坦口服薄膜制剂,用于治疗急性偏头痛,正在与美国食品药品监督管理局讨论新药申请,2015年10月获准在德国上市。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®, (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) 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]

医药 生物科技