Aridis Pharmaceuticals Announces First Quarter 2019 Results

抗感染药物公司 Aridis 发布2019Q1财报,多款新药已提交申请

2019-05-15 08:20:44 BioSpace

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Aridis Pharmaceuticals, Inc.,  , a biopharmaceutical company focused on the discovery and development of targeted immunotherapies using fully human monoclonal antibodies to treat life-threatening bacterial infections, today reported financial and corporate results for the first quarter ended March 31, 2019. First Quarter Highlights Completed enrollment of global Phase 2 clinical trial of AR-105 as a treatment for ventilator-associated pneumonia (VAP) caused by Pseudomonas aeruginosa (P. aeruginosa). Topline data expected in Q3 2019 Initiated Phase 3 global clinical trial of AR-301 targeting gram-positive Staphylococcus aureus (S. aureus) in critically ill VAP patients. Interim data expected in Q1 2020 and top line data expected in late 2020 Continued enrolling patients at a predicted rate in the Phase 1/2a clinical trial of AR-501, an inhalable therapy to treat chronic lung infections impacting cystic fibrosis patients. Top-line data expected in Q1 2020 Filed for Orphan Drug Designation for AR-105 and AR-501 in U.S. and Europe "I'm extremely pleased with the progress achieved during the quarter highlighted by reaching the enrollment completion milestone for AR-105's multi-national Phase 2 clinical trial. This is potentially a landmark study which accesses the clinical utility of using a targeted immunotherapy to treat a life threatening bacterial infection. We continue to be on track for a number of clinical data readouts, starting in the 3rd quarter of this year with AR-105, and in the 1st quarter of next year for AR-301 and AR-501," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. AR-105: The Company is pleased to report that during the first quarter, the enrollment for the program's global Phase 2 study was completed. AR-105 is a broadly active, fully human IgG1 monoclonal antibody targeting VAP caused by gram-negative P. aeruginosa. The trial enrolled 158 patients and the Company expects to have top-line data from the study in the third quarter of 2019.  Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03027609. During the quarter, Aridis also filed for Orphan Drug Designation for AR-105 in U.S. and Europe.  In the U.S., the FDA Office of Orphan Products Development grants orphan drug designation to drugs and biologics which are intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., and may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the U.S. In Europe, orphan designation is also a status assigned to a therapy intended for use in rare diseases. To be granted orphan status by the European Medicines Agency (EMA), the medicine must be intended for the treatment, prevention or diagnosis of a disease that is seriously debilitating and/or life threatening and has a prevalence of up to five in 10,000 in the European Union. Additionally, the intended medicine must aim to provide significant benefit to those affected by the condition. AR-105 has the potential to treat all patient populations infected by P. aeruginosa and is not limited to any subset of P. aeruginosa infected patients. Therefore, pending the outcome of the Phase 2 trial, Aridis will evaluate whether there is a need to embark on a separate Phase 2/3 clinical trial for AR-101, another pipeline product which is a highly specific monoclonal antibody targeting P. aeruginosa lipopolysaccharide serotype O11 that accounts for a subset of approximately 22% of all P. aeruginosa hospital-acquired infections worldwide. AR-301: During the first quarter, a key development milestone for the program was the initiation of a Phase 3 global clinical trial targeting gram-positive S. aureus in critically ill VAP patients. The trial will enroll 240 patients at approximately 140 clinical centers in 20 countries. Participating centers in all countries will follow the same stringent clinical protocols and procedures for critically ill VAP patients, as is standard in the U.S. and Europe. The Investigational New Drug (IND) application to include China among the patient enrolling countries in the study was accepted by the Chinese FDA. Interim data is expected in Q1 2020 and top line data expected in late 2020. AR-301 is an intravenous, broadly active, fully human monoclonal IgG1 antibody, specifically targeting gram-positive S. aureus alpha-toxin. It has been shown in vitro to protect against alpha-toxin mediated destruction of host cells, thereby potentially preserving the human immune response. AR-301's mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA (methicillin resistant S. aureus) and MSSA (methicillin sensitive S. aureus). The trial represents the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute pneumonia in the intensive care unit (ICU) setting. Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03816956. AR-501: During the first quarter, Aridis continued enrolling patients in its Phase 1/2a clinical trial of this inhalable formulation of gallium citrate being evaluated to treat chronic lung infections associated with cystic fibrosis with top-line data expected in Q1 2020. AR-501 is being developed in collaboration with the Cystic Fibrosis Foundation (CF Foundation) and has been granted by the FDA both Fast Track and Qualified Infectious Disease Product (QIDP) designations. The Fast Track designation provides the opportunity to accelerate AR-501's clinical development as it enables more frequent interactions with the FDA while also offering potential eligibility for priority review at the time of license application. The QIDP designation grants a five-year market exclusivity extension and provides priority review for the first application submitted for product approval. Details of the Phase 1/2a clinical trial, which is a randomized, double-blinded, placebo controlled single and multiple dose-ascending trial investigating the safety and pharmacokinetics of inhaled AR-501 in healthy volunteers and cystic fibrosis patients with chronic bacterial lung infections, can be viewed on www.clinicaltrials.gov using identifier NCT03669614. The study will accrue 48 healthy adult volunteers and 48 cystic fibrosis patients from approximately 15 sites in the U.S. During the quarter, Aridis also filed for Orphan Drug Designation for AR-501 in U.S. and Europe. Fiscal First Quarter Results: $16.3 million in cash and cash equivalents as of March 31, 2019 with sufficient capital to fund operations into first quarter 2020 "Our expenses, and the resulting cash burn during the first quarter, were largely due to costs associated with launching the Phase 3 study of AR-301 and the Phase 1/2 study of AR-501. These studies' start-up phases have been largely completed, and we maintain our forecast of cash into the first quarter of 2020," commented Fred Kurland, Aridis' Chief Financial Officer. Revenues: Total revenues for the quarter ended March 31, 2019 were $1.0 million, an increase of $0.7 million over the similar period in 2018 primarily due to the adoption of ASC 606 and the recognition of an additional milestone related to the grant from the CF Foundation. Research and Development Expenses: Research and development expenses for the quarter ended March 31, 2019 were $7.1 million, an increase of $0.5 million over the similar period in 2018 due primarily to an increase in spending on clinical trial activities and drug manufacturing for our AR-301 program, partially offset by decrease in spending on drug manufacturing for our AR-105 program and a decrease in spending on toxicology studies related to our AR-501 program. General and Administrative Expenses: General and administrative expenses for the quarter ended March 31, 2019 were $1.6 million, an increase of $0.6 million over the similar period in 2018 due primarily to an increase in directors' and officers' liabilities insurance expense, an increase in Delaware franchise taxes, and increases in both personnel related expenses and professional service fees. Interest and Other Income, net: Interest and other income, net for the quarter ended March 31, 2019 was $116,000, an increase of approximately $42,000 over the similar period in 2018. These increases were due primarily to a higher rate of return on our cash balance partially offset by a lower average cash balance. Change in Fair Value of Warrant Liability:  As a result of all warrants to purchase preferred stock being converted into warrants to purchase common stock upon our IPO in August 2018, there was no warrant liability recorded in the first quarter of 2019. There was a $38,000 increase in the fair value of warrant liability in the quarter ended March 31, 2018. Net Loss: The net loss available to common shareholders for the quarter ended March 31, 2019 was $8.1 million, or ($0.99) per share, compared to a net loss available to common shareholders of $8.2 million, or ($48.99) per share, for quarter ended March 31, 2018. It should be noted that there were 166,373 common shares outstanding during the first quarter of 2018 and until the completion of the Company's IPO in August 2018. Moreover, there were convertible preferred shares outstanding until the time of the IPO which earned dividends that were distributed as additional shares of preferred stock. All preferred shares were converted to common stock upon the completion of the IPO on August 16, 2018. There were 8.1 million common shares outstanding after the completion of the IPO when all preferred shares were converted to common shares. At December 31, 2018 and at March 31, 2019, there were 8.1 million shares common shares outstanding. About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary MabIgX® technology platform to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection to produce mAbs. These mAbs are already of human origin and functionally optimized for high potency by the donor's immune system, hence they do not require genetic engineering or further optimization to achieve full functionality and high mAb productivity. MabIgX® also allows for the selection of any antibody isotype depending on the optimal effector function required for treating the target infection. By bypassing the humanization and binding sequence optimization steps, and the entire process of generation of genetically engineered antibody producing cell lines, MabIgX® enables high gross-margins and expedited progression to clinical development. The Company has generated multiple clinical stage mAbs targeting bacteria that that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP). The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome, and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The company's pipeline is highlighted below: Aridis' Pipeline AR-301 (ventilator associated pneumonia). AR-301 is a fully human immunoglobulin 1, or IgG1, mAb currently in Phase 3 clinical development targeting gram-positive S. aureus alpha-toxin in ventilator-associated pneumonia, or VAP, patients. AR-105 (ventilator associated pneumonia). AR-105 is a fully human IgG1 mAb targeting gram-negative P. aeruginosa alginate in VAP patients. AR-105 is currently being evaluated in a global Phase 2 clinical study. AR-101 (hospital acquired pneumonia). AR-101 is a fully human immunoglobulin M, or IgM, mAb targeting P. aeruginosa liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide. A plan for the next clinical study will be communicated following the availability of Phase 2 clinical data for AR-105. AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients.  This program is currently in a Phase 1/2a clinical study in healthy volunteers and CF patients. AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii. AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV). For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/. Forward-Looking Statements Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties.  These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially.  There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.  These factors include, but are not limited to, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations.  While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2018 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Aridis Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (in thousands) March 31, December 31, 2019 2018 (unaudited) Cash and cash equivalents $        16,311 $            24,237 Other current and noncurrent assets 6,939 7,374 Total Assets $        23,250 $            31,611 Total Liabilities $          4,541 $              5,297 Total stockholders' equity 18,709 26,314 Total liabilities and stockholders' equity $        23,250 $            31,611 Aridis Pharmaceuticals, Inc. Condensed Consolidated Statements of Operation (in thousands, except share and per share amounts) Three Months Ended March 31, (unaudited) 2019 2018 Revenue $          1,022 $                  322 Operating Expenses* Research and development 7,118 6,626 General and administrative 1,641 1,066 Total operating expenses 8,759 7,692 Loss from operations (7,737) (7,370) Other income (expense) Interest and other income (expense), net 116 74 Change in fair value of warrant liability - (38) Equity in net loss from equity method investment (442) - Net loss $        (8,063) $            (7,334) Preferred dividends $                 - $               (817) Net loss available to common stockholders $        (8,063) $            (8,151) Weighted-average common shares outstanding, basic and diluted 8,105,636 166,373 Net loss per common share, basic and diluted $          (0.99) $            (44.08) Preferred dividends, basic and diluted $                 - $              (4.91) Net loss per share available to common stockholders, basic and diluted $          (0.99) $            (48.99) *Includes stock based-compensation as follows Research and development $              173 $                  141 General and administrative 277 362 $              450 $                  503 Contact: Investor Relations Jason Wong Blueprint Life Science Group jwong@bplifescience.com (415) 375-3340 Ext. 4 multimedia:http://www.prnewswire.com/news-releases/aridis-pharmaceuticals-announces-first-quarter-2019-results-300850196.html
Aridis Pharmaceuticals , Inc .,一家生物制药公司,专注于发现和开发利用全人单克隆抗体治疗威胁生命的细菌感染的靶向免疫疗法,今天报告了截至2019年3月31日的第一季度财务和公司业绩。 第一季亮点 完成 AR-105全球二期临床试验,作为铜绿假单胞菌引起的呼吸机相关性肺炎( VAP )的治疗。二零一九年第三季的主要数据 启动 AR-301靶向 G 阳性金黄色葡萄球菌( S.aureus )治疗重症 VAP 患者的3期全球临床试验。2020年第一季度预计的中期数据和2020年末预计的一线数据 在 AR-501的1/2a 期临床试验中,继续以预测的速度纳入患者,这是一种治疗影响囊性纤维化患者的慢性肺部感染的不可治愈的治疗方法。2020年第一季度预计的一线数据 在美国和欧洲为 AR-105和 AR-501的孤儿药物指定归档 “我非常高兴在本季度取得的进展,通过达到 AR-105多国2期临床试验的注册完成里程碑。这可能是一项具有里程碑意义的研究,它获得了使用有针对性的免疫疗法治疗威胁生命的细菌感染的临床应用。Aridis Pharmaceuticals 首席执行官 Vu Truong 博士评论道:“我们将继续进行多项临床数据的准备工作,从今年第三季度开始进行 AR-105,明年第一季度进行 AR-301和 AR-501。” AR-105:公司很高兴地报告,在第一季度,该计划的全球第二阶段研究的报名工作已经完成。AR-105是一种广泛活性的全人 IgG1单克隆抗体,针对由革兰阴性铜绿假单胞菌引起的 VAP 。该试验纳入了158名患者,公司预计将在2019年第三季度获得该研究的一线数据。这项研究的详细资料可以在 www.clinicaltrials.gov 网站上查阅,使用的标识符是 NCT03027609。 在本季度, Aridis 还在美国和欧洲申请了 AR-105的孤儿药物指定。在美国, FDA 孤儿产品开发办公室( FDA Office of Orphan Products Development )授予孤儿药物指定,用于治疗、诊断或预防影响美国不到20万人的罕见疾病/疾病的药物和生物制剂,并可为临床试验成本、税收优惠、 FDA 使用费利益提供赠款。以及在美国市场七年的独占性。在欧洲,孤儿的指定也被指定为一种用于治疗罕见疾病的治疗方法。要获得欧洲药品管理局( EMA )的孤儿地位,该药品必须用于治疗、预防或诊断一种严重削弱和/或威胁生命的疾病,并在欧盟高达每10000人5人的流行率。此外,预期的药物必须旨在为那些受影响的人提供重要的利益。 AR-105具有治疗所有感染铜绿假单胞菌的患者群体的潜力,并且不限于铜绿假单胞菌感染患者的任何子集。因此,在第二阶段试验的结果出来之前, Aridis 将评估是否需要对 AR-101进行单独的2/3期临床试验,这是另一种管道产品,是一种高度特异性的单克隆抗体,目标是铜绿假单胞菌脂多糖血清型 O11,占全部 P 的大约22%。全球铜绿假单胞菌医院感染. AR-301:在第一季度,该项目的一个关键发展里程碑是启动了针对重症 VAP 患者革兰阳性金黄色葡萄球菌的第3期全球临床试验。该试验将在20个国家的大约140个临床中心招收240名患者。所有国家的参与中心将遵循与美国和欧洲标准相同的严格的 VAP 患者临床规程和程序。研究新药( IND )申请将中国纳入患者注册国,该申请被中国 FDA 接受。中期数据预计在2020年第一季度发布,预计在2020年末发布一线数据。 AR-301是一种静脉注射的、广泛活性的全人单克隆抗体 IgG1,特别针对革兰阳性的金黄色葡萄球菌甲型毒素。它已在体外显示,以防止阿尔法毒素介导的破坏宿主细胞,从而潜在地保持人类免疫反应。AR-301的作用方式独立于 S 。金葡菌和金葡菌对 MRSA (耐甲氧西林金黄色葡萄球菌)和 MSSA (耐甲氧西林金黄色葡萄球菌)引起的感染均有活性。该试验是第一次在重症监护病房( ICU )设置中,用全人源单克隆抗体评价免疫治疗的第3期优势临床研究。这项研究的详细资料可在 www.clinicalrials.gov 网站上查阅,使用的标识符是 NCT03816956。 AR-501:在第一季度, Aridis 继续将患者纳入其第1/2a 期临床试验,该试验是对这种不可吸入的枸橼酸镓制剂进行评估,以治疗与囊性纤维化相关的慢性肺部感染,其一线数据预计在2020年第一季度。AR-501是与囊性纤维化基金会( CF 基金会)合作开发的,已获得 FDA 的快速通道和合格传染病产品( QDP )指定。快速通道的指定提供了加速 AR-501的临床发展的机会,因为它使更频繁的互动与 FDA 同时也提供了潜在的资格优先审查在申请许可时。QDP 指定授予五年的市场独占性扩展,并为提交产品批准的第一个申请提供优先审查。 期1/2a 临床试验的详情,该试验是一项随机、双盲、安慰剂对照的单剂量和多剂量递增试验,研究吸入 AR-501在健康志愿者和慢性细菌性肺部感染囊性纤维化患者中的安全性和药代动力学。可通过使用标识符 NCT03669614在 www.clinicaltrials.gov 上查看。这项研究将使48名健康的成人志愿者和48名囊性纤维化患者从大约15个地点在美国。在本季度, Aridis 还在美国和欧洲申请了 AR-501的孤儿药物指定。 财年第一季度业绩:截至2019年3月31日的现金及现金等价物为1630万美元,资本充足,足以为2020年第一季度的运营提供资金 「我们的开支及第一季的现金消耗,主要是由于展开 AR-301第三期研究及 AR-501第一/2期研究的相关成本。Aridis 首席财务官 Fred Kurland 说:“这些研究的启动阶段已经基本完成,我们将现金预测维持到2020年第一季度。” 收入:截至2019年3月31日止季度的总收入为1.0百万美元,较2018年同期增加0.7百万美元,主要由于采用 ASC 606及确认与 CF 基金会赠款相关的额外里程碑。 研发费用:截至2019年3月31日止季度的研发费用为710万美元,较2018年同期增加50万美元,主要由于 AR-301计划的临床试验活动和药品制造支出增加所致;部分被 AR-105计划的药物制造支出减少和与 AR-501计划相关的毒理学研究支出减少所抵消。 一般及行政开支:截至2019年3月31日止季度的一般及行政开支为1.6百万美元,较2018年同期增加0.6百万美元,主要由于董事及高级职员责任保险开支增加、特拉华州特许经营税增加、以及人员相关费用和专业服务费的增加。 利息及其他收入净额:利息及其他收入净额截至2019年3月31日止季度为116,000美元,较2018年同期增加约42,000美元。这些增加主要由于现金结余回报率较高,部分被平均现金结余较低所抵销。 认股权证负债公允价值变动:由于所有认股权证于2018年8月首次公开发行时转换为认股权证购买普通股,故2019年第一季度并无认股权证负债记录。截至2018年3月31日止季度,认股权证负债的公允价值增加38,000美元。 净亏损:截至2019年3月31日止季度,普通股股东可获得的净亏损为810万美元,或每股(0.99美元),而截至2018年3月31日止季度,普通股股东可获得的净亏损为820万美元,或每股(48.99美元)。应注意,于2018年第一季度及直至本公司于2018年8月完成首次公开发行前,已发行166,373股普通股。此外,还有可转换优先股在首次公开发行( IPO )前发行,获得的股息作为优先股的额外股份分配。所有优先股于2018年8月16日完成首次公开发行后转为普通股。首次公开发行完成后,当所有优先股转换为普通股时,有810万股已发行普通股。2018年12月31日、2019年3月31日,发行在外普通股810万股。 关于 Aridis Pharmaceuticals , Inc . Aridis Pharmaceuticals , Inc .发现并开发抗感染药物,用于标准护理抗生素的附加治疗。本公司正利用其专有的 MabIgX ®技术平台,从成功克服感染的患者中快速识别罕见的、有效的抗体产生 B 细胞,以产生 mAbs 。这些 mAbs 已经是人类起源的,并且通过供体免疫系统对其进行功能优化,因此不需要基因工程或进一步优化来实现完全功能和高 mAb 的生产力。MabIgX ®还允许根据治疗目标感染所需的最佳效果函数来选择任何抗体同类型。通过绕过人性化和结合序列优化步骤,以及产生基因工程抗体产生细胞株的整个过程, MabIgX ®实现了高毛利,并加快了临床开发的进程。 本公司已产生多个临床阶段的 mAbs 靶向细菌,这些细菌导致呼吸机相关肺炎( VAP )和医院获得性肺炎( HAP )等威胁生命的感染。使用 mAbs 作为抗感染治疗手段代表了一种创新的治疗方法,利用人体免疫系统对抗感染,旨在克服目前的治疗标准,即广谱抗生素的缺陷。这些缺陷包括但不限于提高耐药性、短期疗效、破坏人体微生物群的正常菌群、以及目前治疗方法之间缺乏分化。mAb 组合由正在开发的治疗囊性纤维化患者肺部感染的非抗生素新型机制小分子抗感染候选药物补充。公司管道突出显示如下: Aridis 管道 AR-301(呼吸机相关肺炎)。AR-301是一种全人免疫球蛋白1,或 IgG1, mAb ,目前处于3期临床开发中,针对革兰阳性 S 。呼吸机相关性肺炎( VAP )患者的金黄色葡萄球菌α毒素. AR-105(呼吸机相关肺炎)。AR-105是一种完全人类 IgG1mAb 靶向克阴性 P 。VAP 患者铜绿假单胞菌藻酸盐的研究.AR-105目前正在全球2期临床研究中进行评估。 AR-101(医院获得性肺炎)。AR-101是完全人免疫球蛋白 M ,或 IgM , mAb 靶向 P 。铜绿假单胞菌脂多糖血清型 O11,约占全部 P 的22%。铜绿假单胞菌医院在全球范围内获得肺炎病例。下一次临床研究的计划将在 AR-105的第2阶段临床数据可用性之后进行沟通。 AR-501(囊性纤维化)。AR-501是一种吸入的枸橼酸镓制剂,具有广谱抗感染活性,用于治疗囊性纤维化患者的慢性肺部感染。该项目目前正处于健康志愿者和 CF 患者的1/2a 临床研究阶段。 AR-401(血液流感染)。AR-401是一个完整的人 mAb 临床前计划,旨在治疗革兰阴性鲍曼不动杆菌引起的感染。 AR-201( RSV 感染)。AR-201是一个完全人 IgG1mAb 临床前计划,旨在中和各种临床分离的呼吸道合胞病毒( RSV )。 有关 Aridis Pharmaceuticals 的更多信息,请访问 https://aridisharma 。com /。 前瞻性陈述 本新闻稿中的某些声明是前瞻性声明,涉及多项风险和不确定性。这些陈述可以通过使用诸如“预期”、“相信”、“预测”、“估计”和“意图”等词或涉及 Aridis 的期望、策略、计划或意图的其他类似术语或表达来识别。这些前瞻性陈述基于 Aridis 目前的预期,实际结果可能存在重大差异。有若干因素可能导致实际事件与这些前瞻性陈述所表明的事件有重大差异。这些因素包括但不限于监管提交的时间、 Aridis 获得并保持其现有产品候选者以及其可能开发的任何其他产品候选者的监管批准的能力、临床试验的批准可能被监管机构延迟或拒绝。与临床试验的时间和成本、与从第三方获得资金相关的风险、管理和员工运营和执行风险、关键人员流失、竞争、与产品的市场接受相关的风险、知识产权风险、与未来财务业绩不确定性相关的风险;Aridis 吸引合作者和合作伙伴的能力以及与 Aridis 依赖第三方组织相关的风险。虽然此处列出的因素清单具有代表性,但不应将此清单视为所有潜在风险和不确定性的完整说明。未列入清单的因素可能对实现前瞻性陈述构成重大的额外障碍。实际结果可能因各种重要因素(包括但不限于市场条件以及 Aridis'10-K 中截至12月31日的年度“风险因素”标题下描述的因素)而与此类前瞻性陈述描述或暗示的结果存在重大差异。2018年和 Aridis 向美国证券交易委员会提交的其他文件。本协议包含的前瞻性陈述自本协议签订之日起作出, Aridis 不承担任何义务公开更新该等陈述以反映后续事件或情况。 Aridis Pharmaceuticals , Inc . 简明综合资产负债表 (千人) 3月31日, 12月31日, 2019年 2018年 (未经审核) 现金及现金等价物 16,311美元 24,237元 其他流动和非流动资产 6,939 7,374 总资产 23,250元 31,611美元 负债总额 $4,541 $5,297 股东权益合计 18,709 26,314 负债和股东权益总额 23,250元 31,611美元 Aridis Pharmaceuticals , Inc . 简明综合经营报表 (以千计,股份及每股金额除外) 三个月已完结 3月31日, (未经审核) 2019年 2018年 收入 $1,022 322元 经营开支* 研究与开发 7,118 6,626 一般事务和行政事务 1,641 1,066 经营费用总额 8,759 7,692 经营损失 (7,737) (7,370) 其他收入(费用) 利息和其他收入(支出),净额 116 74 认股权证负债公平值变动 - (38) 权益法投资净损失中的权益 (442) - 净损失 $(8,063) $(7,334) 优先股息 $- $(817) 普通股股东的净损失 $(8,063) $(8,151) 已发行、基本及摊薄的加权平均普通股 8,105,636 166,373 每股普通股净亏损,基本及摊薄 $(0.99) $(44.08) 优先股息,基本及摊薄 $- $(4.91) 普通股股东每股净亏损,基本及摊薄 $(0.99) $(48.99) *包括股份补偿如下 研究与开发 173美元 141元 一般事务和行政事务 277 362 450元 503元 联系方式: 投资者关系 Jason Wong Blueprint Life Science Group jwong @ bplifescience.com (415)375-3340 Ext 。4 多媒体: http://www.prnewswire.com/news-diseases/aridis-Pharmaceuticals-annound-first-products-300850196。html

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