Check-Cap signs second trial site, beats Street on Q1 loss


2019-05-15 18:40:00 Mass Device


Check-Cap said today that Mayo Clinic has signed on as the second trial site in the U.S. pilot study of the company’s C-Scan colorectal cancer-screening system. The single-arm study to evaluate the safety and usability of the X-ray-enabled, cancer-screening capsule will enroll up to 45 adults considered to be at average risk for polyps and colon cancer. It began last month. The C-Scan system uses an ultra-low dose X-ray capsule, an integrated positioning, control, and recording system, and proprietary software to generate a 3D map of the inner lining of the colon without the need for laxatives or an invasive procedure. It received approval from Israel’s Ministry of Health Medical Device division (AMAR) and the CE Mark in 2018. AMAR recently gave the Isfiya, Israel-based startup an extension to begin commercial sales of C-Scan in Israel, valid until March 31, 2020. “We are thrilled to collaborate with Mayo Clinic as a part of our U.S. pilot study of the C-Scan system,” said Check-Cap CEO Alex Ovadia in a news release. “Together with the continued progress being made at our first trial site, the New York University School of Medicine, we are advancing this study, and look forward to final results later this year as we prepare for a U.S. pivotal study.” Check-Cap also reported first-quarter earnings today, just slightly beating analysts’ per-share earnings projections. The company said it lost $3.146 million in the quarter ended March 31, 2019, compared with a loss of $2.127 million in the same quarter last year. It also increased R&D spending by 44% to $3.6 million during the quarter. It posted a per-share net loss of 0.44¢, besting Q1 2018’s $1.27 net loss and analysts’ consensus of -0.46¢. Investors reacted by sending CHEK stock down 6% to $2.18 per share at the close. In February, the company inked a direct registered offering deal worth approximately $7.5 million to advance the clinical development of C-Scan in the U.S. “We believe the availability of a patient-friendly, preparation-free colon cancer screening alternative such as C-Scan can fundamentally alter the screening and prevention paradigm and significantly increase screening rates globally, leading to improved outcomes for patients while creating long-term value for our shareholders,” Ovadia said.
Check-Cap 今天表示, Mayo Clinic 已签约成为该公司 C-Scan 结直肠癌筛查系统美国试验性研究的第二个试验点。 单臂研究,以评估安全和可用性的 X 射线支持,癌症筛选胶囊将纳入多达45个成年人被认为是平均风险的息肉和结肠癌。上个月开始了。 C-Scan 系统使用超低剂量 X 射线胶囊、集成的定位、控制和记录系统以及专有软件来生成结肠内衬里的3D 地图,而无需药物或侵入性程序。2018年获得以色列卫生部医疗器械部门( AMAR )和 CE 标志的批准。AMAR 最近给了 Isfiya ,这家总部位于以色列的初创公司延长了 C-Scan 在以色列的商业销售期限,有效期至2020年3月31日。 “作为美国 C-Scan 系统试验性研究的一部分,我们很高兴与梅奥诊所( Mayo Clinic )合作,” Check-Cap 首席执行官亚历克斯·奥瓦迪亚( Alex Ovadia )在新闻稿中说。“连同我们第一个试验地点纽约大学医学院的持续进展,我们正在推进这项研究,并期待着在今年晚些时候为美国的一项关键研究做准备时取得最终结果。” Check-Cap 今日也公布了第一季度收益,略高于分析师的每股收益预期。该公司表示,截至2019年3月31日的季度亏损341.6万美元,去年同期亏损212.7万美元。该季度还将研发支出增加44%,至360万美元。 该公司公布的每股净亏损为0.44%,超过2018年第一季度1.27美元的净亏损和分析师对-0.46%的共识。投资者的反应是,在收盘时, CHK 股价下跌6%,至每股2.18美元。 今年2月,该公司签署了价值约750万美元的直接注册发行协议,以推进 C-Scan 在美国的临床开发。 奥瓦迪亚表示:“我们相信,提供一种方便患者、无准备的结肠癌筛查替代方案,如 C-Scan ,可以从根本上改变筛查和预防模式,并显著提高全球的筛查速度,从而改善患者的结果,同时为我们的股东创造长期价值。”