核心亮點如下:
RedHill Biopharma (NASDAQ/TASE: RDHL) 今天披露了截至2015年12月31日的全年財報。
RedHill繼續維持強勁、無負債的資產負債表表現,截至2015年年底,現金和現金等價物約為$5800萬美元,使公司能夠繼續實施開發計劃。
2015年的重要里程碑包括:RHB-105治療幽門螺旋桿菌感染的首個三期試驗以及YELIVA™治療晚期實體瘤的一期試驗取得積極結果,急性偏頭痛藥物RIZAPORT™在德國拿到歐洲市場的第一個上市許可。
2016年有望實現的部分里程碑包括:預計將在2016年下半年發布RHB-104治療克羅恩病的三期試驗中期分析報告,預計將在2016年下半年發布BEKINDA™治療腸胃炎的三期試驗結果,預計將在未來幾週發布RHB-104治療多發性硬化症的二a期概念驗證試驗中期結果,以及啟動RHB-105治療幽門螺旋桿菌的三期驗證試驗。
請參閱附件查看完整的公司財報。 RedHill還召開了電話會議來回顧財務結果和業務亮點。歡迎登陸公司網站http://ir.redhillbio.com/events.cfm重看網絡直播,視頻有效期為30天。
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是以色列一家新興的生物醫藥公司,致力於開發和商業化治療炎症性疾病和腸胃疾病(包括癌症)的處於後期臨床試驗階段、專有的、口服的小分子藥。公司目前的產品管線包括:(i) RHB-105 -治療幽門螺桿菌感染的口服混合藥,首個三期試驗獲得成功;(ii) RHB-104 -治療克羅恩病的口服混合藥,正在進行首個三期試驗以及治療多發性硬化症的二a期概念驗證試驗;(iii) BEKINDA™ (RHB-102) -日服一次的昂丹司瓊口服藥片製劑,正在美國進行治療急性腸胃炎和慢性胃炎的三期試驗,併計劃進行治療腹瀉腸易激綜合徵的二期試驗;(iv) RHB-106 -腸道準備藥物膠囊,已經授權給Salix Pharmaceuticals Ltd.;(v) YELIVA™ ( ABC294640) -口服SK2選擇性抑製劑,是首創新藥,靶向為多種腫瘤、炎症性和胃腸道適應症,已經啟動治療難治的/惡化的擴散性的大B細胞淋巴瘤的一/二期試驗;(vi) MESUPRON® – 處於二期試驗階段的uPA抑製劑口服膠囊,是首創新藥,靶向為胃腸和其他實體瘤;(vii) RP101 – Hsp27抑製劑口服藥片,是處於二期試驗階段的首創新藥,靶向為胰腺癌和其他胃腸癌,RedHill擁有該藥物的收購選擇權;(viii) RIZAPORT™ (RHB-103) -利扎曲坦口服薄膜製劑,用於治療急性偏頭痛,正在與美國食品藥品監督管理局討論新藥申請,2015年10月獲准在德國上市;以及(ix) RHB-101 -心血管藥物卡維地洛日服一次的口服藥片製劑。
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 develop ment 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 establish and maintain corporate collaborations; (vi) 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; (vii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (viii) the scope of protection t he 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; (ix) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (x) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xi) competitive companies and technologies within the Company’s industry; and (xii) the impact of the political and security situation in Israel on the Company’s business. 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 26, 2015. All forward-looking statements included in this Pr ess 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.
公司聯繫人:
Adi Frish
業務發展和許可高級副總裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投資者關係聯繫人(美國):
Marcy Nanus
高級副總裁
The Trout Group
+1-646-378-2927
[email protected]