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ProMIS Neurosciences (PMN) - 2024 Q2 - Quarterly Report
2024-08-08 20:05
产品研发 - 公司正在开发针对神经退行性疾病的抗体疗法和治疗性疫苗[122] - 公司的主要产品候选药物包括PMN310、PMN267和PMN442[123] - PMN310是公司的主要产品候选药物,正在进行首次人体试验,结果显示PMN310在脑脊液中的浓度随剂量增加而成比例增加,半衰期约为25天[130][137] - 公司计划在2024年下半年启动PMN310的1b期临床试验,这是一项随机、安慰剂对照、双盲的临床试验,预计将入组100名阿尔茨海默病患者[131][137] - 公司还在推进针对ALS和多系统萎缩症的其他产品候选药物的研发[133][134] - 公司正在利用机器学习技术来优化其发现算法,加快识别和专利化疾病特异性表位及相应抗体的能力[136] 财务情况 - 研发费用同比下降17%,主要是咨询费用减少[156][157] - 一般及行政费用同比下降21%,主要是专业咨询费用减少[161][162] - 其他收益同比下降0.5百万美元,主要是金融工具公允价值变动收益减少[163] - 2024年6月30日三个月研发费用同比增加62%,主要是PMN310临床试验费用增加[172] - 2024年6月30日三个月一般及行政费用同比下降43%,主要是专业咨询费用减少[177] - 公司于2023年8月完成2040万美元的私募股权融资[180] - 公司于2024年7月完成3030万美元的私募股权融资[182][183][184] - 管理层认为2024年7月的私募融资可为公司提供足够的现金支持运营至2026年[185] - 未来公司可能需要通过公开或私募融资、债务融资、合作等方式获得更多资金支持[186] - 公司预计未来将继续需要大量资本以开发当前和未来的产品候选药物,并为可预见的未来提供运营资金[188] - 公司将寻求通过私募或公开股权或债务融资、贷款或其他资本来源筹集所需的额外资本[189] - 公司的未来资金需求将取决于多个因素,包括研发和临床试验的范围、时间进度、结果和成本[190] - 公司2024年上半年的经营活动现金流出为1,179.6万美元,主要由于净亏损630万美元和经营资产负债变动净额560万美元[195] - 公司2023年上半年的经营活动现金流出为470.9万美元,主要由于净亏损730万美元,部分被非现金活动和经营资产负债变动抵消[196] - 公司2024年上半年的融资活动现金流入为19.0万美元,来自于按市场发行普通股[197] - 公司2023年上半年无融资活动现金流[198] 其他 - 公司采用了JOBS法案下的新兴成长公司过渡期,可能导致财务报表与遵守新会计准则的公司不具可比性[201,202] - 截至2024年6月30日,公司已发行在外的普通股等价物总数为3,460.4万股[203-206]
ProMIS Neurosciences (PMN) - 2024 Q2 - Quarterly Results
2024-08-08 20:00
临床试验进展 - 公司完成了首次人体I期临床试验,PMN310在健康受试者中表现良好,耐受性和安全性良好,药代动力学数据令人鼓舞[2][10][11][12] - PMN310设计用于专一性地结合有毒的淀粉样蛋白寡聚体,避免与淀粉样斑块的结合,预计不会出现ARIA等严重副作用[7] 融资情况 - 公司获得高达1.227亿美元的私募融资,用于支持PMN310在阿尔茨海默病患者中的I期b期临床试验[3][18] - 公司二季度现金及现金等价物为100万美元,完成私募融资后获得3030万美元初始资金,并有潜在的9240万美元跟进融资[19] 研发项目进展 - 公司正在推进针对阿尔茨海默病的疫苗项目,基于其寡聚体靶标表位,展示了最大免疫反应性的数据[14] - 公司发表了两篇论文,阐述了SOD1聚集体在ALS发病机理中的作用[16] - 公司发表了支持PMN267作为ALS潜在治疗药物的前期临床数据[17] 财务数据 - 公司总营业费用为639.0万美元,较上年同期下降18.8%[30] - 研发费用为374.9万美元,较上年同期下降16.9%[30] - 管理费用为264.0万美元,较上年同期下降21.3%[30] - 净亏损为625.8万美元,较上年同期下降13.9%[30] - 每股基本和稀释亏损为0.32美元,较上年同期下降62.4%[30] - 普通股加权平均股数为1,954.4万股,较上年同期增加128.0%[30] - 公司获得其他收益1.6万美元,较上年同期增加95.3%[30] - 公司金融工具公允价值变动收益为4.4万美元,较上年同期下降92.0%[30] - 公司利息费用为7.6万美元,较上年同期增加56.3%[30]
ProMIS Neurosciences to Participate in BTIG Virtual Biotechnology Conference 2024
GlobeNewswire News Room· 2024-08-01 19:00
CAMBRIDGE, Massachusetts and TORONTO, Ontario, Aug. 01, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of therapeutics targeting toxic misfolded proteins in neurodegenerative diseases, today announced that Neil Warma, interim Chief Executive Officer of ProMIS Neurosciences and Larry Altstiel, M.D., Ph.D., Chief Medical Officer of ProMIS Neurosciences, will participate in a fireside chat at the BTIG Virtual Biotechnology Con ...
ProMIS Neurosciences Showcases Novel Vaccine Approach for Maximal Targeting of Toxic Amyloid-Beta Oligomers at the 2024 Alzheimer's Association International Conference
Newsfilter· 2024-07-30 20:30
Preclinical data showed strong antibody responses with no measurable pro-inflammatory T cell responses against AßO and support novel approach for potential Alzheimer's disease vaccine CAMBRIDGE, Massachusetts and TORONTO, Ontario, July 30, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (NASDAQ:PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer's disease (AD), amyotrophic late ...
ProMIS Neurosciences Reports Positive Top-Line Data from its Phase 1a Alzheimer's Trial
Newsfilter· 2024-07-26 20:35
Topline results demonstrated a favorable safety profile and tolerability across four ascending dose levels in healthy volunteers and showed dose dependent levels of PMN310 antibody in Cerebrospinal fluid (CSF) suggestive of its potential for target engagement in Alzheimer's disease patients CAMBRIDGE, Massachusetts and TORONTO, Ontario, July 26, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (NASDAQ:PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeti ...
ProMIS Neurosciences Reports Positive Top-Line Data from its Phase 1a Alzheimer's Trial
GlobeNewswire News Room· 2024-07-26 20:35
Topline results demonstrated a favorable safety profile and tolerability across four ascending dose levels in healthy volunteers and showed dose dependent levels of PMN310 antibody in Cerebrospinal fluid (CSF) suggestive of its potential for target engagement in Alzheimer’s disease patients CAMBRIDGE, Massachusetts and TORONTO, Ontario, July 26, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics target ...
ProMIS Neurosciences Announces Up to $122.7 Million Private Placement Financing
GlobeNewswire News Room· 2024-07-26 20:30
$30.3 million financing upfront with up to an additional $92.4 million tied to exercise of warrants, with certain of the warrants subject to shareholder approval Fundraise supports development of novel antibody PMN310 for Alzheimer’s Disease patients Proceeds expected to support Company beyond 6 month and 12 month data from the PMN310 Phase Ib study in Alzheimer’s patients TORONTO, Ontario and CAMBRIDGE, Massachusetts, July 26, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN) (“ProMIS” or th ...
ProMIS Neurosciences (PMN) - 2024 Q1 - Quarterly Report
2024-05-15 04:31
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-41429 PROMIS NEUROSCIENCES INC. (Exact name of Registrant as specified in its Charter) Ontario, Canada 98-0647 ...
ProMIS Neurosciences (PMN) - 2024 Q1 - Quarterly Results
2024-05-15 04:25
Exhibit 99.1 ProMIS Neurosciences Announces First Quarter 2024 Financial Results and Recent Highlights Top-line data from first-in-human Phase 1a clinical trial of PMN310 as a treatment for Alzheimer’s disease on track for mid-2024 CAMBRIDGE, Massachusetts and TORONTO, Ontario – May 14, 2024 – ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such ...
ProMIS Neurosciences (PMN) - 2023 Q4 - Annual Report
2024-04-02 04:21
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission file number: 001-41429 PROMIS NEUROSCIENCES INC. (Exact name of registrant as specified in its charter) Ontario, Canada 98-0647155 (State of O ...