KalVista Pharmaceuticals Reports Fiscal First Quarter Results of 2019

制药公司KalVista公布2019财年一季度财报:营收340万美元,净亏损730万美元

2019-09-11 19:00:00 BioSpace

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KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal first quarter ended July 31, 2019. “With enrollment complete in our Phase 2 trial for KVD001, we expect data in the fourth quarter of 2019,” said Andrew Crockett, Chief Executive Officer of KalVista. “Our second ongoing Phase 2 trial, with KVD900 for on-demand treatment of hereditary angioedema attacks is currently enrolling, and we continue to expect to complete that trial late this year. On the research side, our team continues to work on our earlier stage programs including KVD824, for which we expect to announce further development plans in the first half of 2020.” First Quarter and Recent Business Highlights: Opened an Investigational New Drug (IND) Application for KVD900 with the U.S. Food and Drug Administration (FDA) to enable clinical development in the United States. Fiscal First Quarter Financial Results: Revenue: Revenue was $3.4 million for the three months ended July 31, 2019, compared to $3.7 million for the same period in 2018. Revenue in the three months ended July 31, 2019 consisted of the recognition of a portion of the upfront payment from Merck related to the agreement signed in October 2017. R&D Expenses: Research and development expenses were $9.7 million for the three months ended July 31, 2019, compared to $8.4 million for the same period in 2018. The increase in R&D expense primarily reflects the ongoing clinical trial for KVD900 and an increase in preclinical activities. These increases in expense were somewhat offset by a decrease in expense related to KVD001 as it heads toward completion of a Phase 2 clinical trial later this year. G&A Expenses: General and administrative expenses were $3.2 million for the three months ended July 31, 2019, compared to $2.4 million for the same period in 2018. The increase was primarily due to an increase in compensation related expenses and professional fees in the three months ended July 31, 2019 compared to those incurred in the same period in 2018. Net Loss: Net loss was $7.3 million, or $(0.42) per basic and diluted share for the three months ended July 31, 2019, compared to a net loss of $5.0 million, or $(0.47) per basic and diluted share, for the same period in 2018. Cash: Cash, cash equivalents and marketable securities were $100.4 million as of July 31, 2019. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body’s inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. The Company has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and commenced a Phase 2 proof-of-concept study in HAE patients in late 2018. In DME, KalVista’s most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, began a Phase 2 clinical trial in 2017 that is anticipated to report data in the fourth quarter of 2019.
KalVista Pharmaceuticals , Inc .( NASDAQ : KALV ),一家专注于发现、开发和商业化小分子蛋白酶抑制剂的临床阶段制药公司,今天提供了最新的运营信息,并公布了截至2019年7月31日的第一财政季度的财务业绩。 KalVista 首席执行官安德鲁•克罗克特( Andrew Crockett )表示:“随着 KVD001二期试验的报名工作完成,我们预计2019年第四季度的数据会出现。”“我们正在进行的第二阶段试验, KVD900用于按需治疗遗传性血管水肿攻击,目前正在注册,我们预计将在今年晚些时候完成该试验。在研究方面,我们的团队继续致力于我们早期的项目,包括 KVD824,我们预计在2020年上半年宣布进一步的发展计划。” 第一季度及近期业务重点: 与美国食品药品监督管理局(Food and Drug Administration)( FDA )共同启动了一项研究新药( IND )申请 KVD900,以支持美国的临床开发。 财务第一季度财务业绩: 收入:截至2019年7月31日止三个月的收入为340万美元,而2018年同期为370万美元。截至2019年7月31日止三个月的收入包括确认默克(Merck)与2017年10月签署的协议相关的部分前期付款。 研发费用:截至2019年7月31日止三个月的研发费用为970万美元,而2018年同期为840万美元。研发费用的增加主要反映了 KVD900正在进行的临床试验以及临床前活动的增加。由于 KVD001即将于今年晚些时候完成第二期临床试验,费用的增加被费用的减少部分抵消。 G & A 费用:截至2019年7月31日止三个月的一般及行政费用为320万美元,而2018年同期为240万美元。增加的主要原因是截至2019年7月31日止三个月薪酬相关费用及专业费用较2018年同期增加所致。 净亏损:截至2019年7月31日止三个月,净亏损为7.3百万美元,或每股基本及摊薄股份(0.42美元),而2018年同期则为净亏损5.0百万美元,或每股基本及摊薄股份(0.47美元)。 现金:截至2019年7月31日,现金、现金等价物和有价证券为10,040万美元。 关于 KalVista 制药公司。 KalVista Pharmaceuticals , Inc .是一家专注于发现、开发和商业化的小分子蛋白酶抑制剂的制药公司,用于治疗需求明显未得到满足的疾病。最初的重点是血浆激肽激酶抑制剂,它是机体炎症反应的一个重要组成部分,过量会导致血管通透性、水肿和炎症增加。KalVista 公司开发了一系列新的小分子血浆激肽抑制剂,最初针对遗传性血管性水肿( HAE )和糖尿病黄斑水肿( DME )。该公司已经建立了一个结构多样的口服血浆激肽抑制剂组合,并正在推进多个候选药物的港机工程和二甲醚。本公司已选定 KVD900作为其计划,以按需治疗急性港机工程攻击,并于2018年底开始在港机工程患者进行第二期概念验证研究。在 DME , KalVista 最先进的项目,一种被称为 KVD001的玻璃体内注射血浆激肽抑制剂,在2017年开始了第二期临床试验,预计将在2019年第四季度报告数据。

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