SAN FRANCISCO, Oct. 24, 2024 (GLOBE NEWSWIRE) -- On October 17, 2024, the U.S. Federal Food & Drug Administration (“FDA”) published its April 5, 2024 report addressed to Humacyte’s Chief Operating Officer (Heather Prichard) detailing problems with Humacyte’s facilities. The FDA’s April 5, 2024 report submitted to Prichard appears to potentially contradict her assurances to investors at an earnings call on May 12, 2024 in response to analyst questions. Hagens Berman urges investors in Humacyte, Inc. (NASDAQ: ...

In the latest market close, Humacyte, Inc. (HUMA) reached $5.70, with a +0.53% movement compared to the previous day. This change outpaced the S&P 500's 0.76% loss on the day. Meanwhile, the Dow lost 0.75%, and the Nasdaq, a tech-heavy index, lost 1.01%. Shares of the company have appreciated by 7.39% over the course of the past month, outperforming the Medical sector's loss of 3.35% and the S&P 500's gain of 4.31%. Market participants will be closely following the financial results of Humacyte, Inc. in its ...

DURHAM, N.C., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its late-breaking abstract on the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients with end-stage renal disease was accepted for an oral presentation at the American Society of Nephrology's (ASN) Kidney Week 2024. The la ...

DURHAM, N.C., Oct. 04, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it entered into a securities purchase agreement with an institutional investor to purchase approximately $30.0 million worth of its common stock and warrants in a registered direct offering. Under the terms of the securities purchase agreement, the Company has agreed to sell 5,68 ...

The most recent trading session ended with Humacyte, Inc. (HUMA) standing at $5.46, reflecting a +0.09% shift from the previouse trading day's closing. This move lagged the S&P 500's daily gain of 0.4%. At the same time, the Dow added 0.62%, and the tech-heavy Nasdaq gained 0.6%. Heading into today, shares of the company had lost 15.43% over the past month, lagging the Medical sector's loss of 2.27% and the S&P 500's gain of 1.71% in that time. The investment community will be paying close attention to the ...

DURHAM, N.C., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced it will host a virtual KOL event on Monday, September 30, 2024 at 8:00 AM ET. To register, click here. The event will feature Charles Fox, MD (University of Maryland School of Medicine), Rishi Kundi MD, RPVI, FACS, FSVS (University of Maryland School of Medicine), and YingWei Lum, MD ...

Originally a Biologist, M.Sc in Biomedicine, PhD in Bioengineerings, and +20 years experience in the research and development of novel Cell & Gene Therapies (CGT) tackling several clinical needs including orthopaedics and rare diseases. As an investor, I have been utilising my background in life sciences to assess the potential of novel treatments, including those using CGT, as well as, their capacity to drive shareholders' returns. Thus, as SA analyst, I will be focusing on analysing biotechnology, pharmac ...

When deciding whether to buy, sell, or hold a stock, investors often rely on analyst recommendations. Media reports about rating changes by these brokerage-firm-employed (or sell-side) analysts often influence a stock's price, but are they really important? Let's take a look at what these Wall Street heavyweights have to say about Humacyte, Inc. (HUMA) before we discuss the reliability of brokerage recommendations and how to use them to your advantage. Humacyte, Inc. currently has an average brokerage recom ...

Humacyte, Inc. (HUMA) announced a delay in the FDA's review of its Biologic License Application (BLA) for its Acellular Tissue Engineered Vessel (ATEV). The FDA, which had granted a Priority Review to this pioneering vascular trauma treatment, now requires additional time beyond the original Prescription Drug User Fee Act (PDUFA) date of Aug 10, 2024, to complete its evaluation. Despite the delay, Humacyte remains confident about ATEV's potential approval and its transformative role in trauma care. Humacyte ...

财务状况 - 公司现金及现金等价物为9,391.6万美元，较上年末增加13,115万美元[33] - 公司发行股票筹集资金4,339.6万美元，扣除承销费用后净额为4,304.6万美元[32] - 公司通过收益权购买协议筹集资金2,000万美元，扣除发行费用后净额为1,950万美元[32] - 公司自2004年成立以来一直未产生产品收入，并在每年都产生经营亏损和负现金流[39] - 公司主要通过股权融资、可转债、反向重组交易收益、贷款和收益权购买协议等方式为运营提供资金[39] - 截至2024年6月30日和2023年12月31日，公司累计亏损分别为6.259亿美元和5.373亿美元[39] - 公司需要在2024年8月17日前向受限现金账户注资5400万美元，其中5000万美元受限制[42] - 如果公司无法按时注资或获得ATEV产品上市批准并产生足够商业销售现金流，将存在持续经营重大不确定性[43] - 公司的现金及现金等价物余额为9360万美元[43] 研发和商业化 - 公司研发费用为4,501.7万美元，较上年同期增加18.9%[22] - 公司正在开发生物工程人体组织、先进组织构建和器官系统等再生医学产品[37] - 公司目前正在开发的产品候选药物需要进行大量的临床前和临床试验以及监管审批才能商业化，这需要大量的额外资本、合适的人员和基础设施以及广泛的合规报告能力[63] - 公司可能依赖与Fresenius Medical Care的战略合作关系来分销其产品，包括在美国以外销售和分销其6毫米ATEV的某些特定适应症[63] - 公司已完成V007 III期临床试验的患者入组，并在2024年7月宣布该试验取得积极的主要终点结果[196] - 公司预计未来一段时间内将继续大幅增加研发和商业化支出，以推进产品候选药的开发和商业化[201,202] - 公司研发支出主要用于ATEV的III期临床试验和监管申报,以及扩大生产能力等[205,206,207,208] 费用管控 - 公司一般及行政费用为1,106万美元，较上年同期下降3.2%[22] - 公司预计未来一段时间内一般及行政费用将持续增加，以支持公司的基础设施建设和公众公司的运营[209,210] 财务报表披露 - 公司将其现金等价物(货币市场基金)归类为公允价值层级第1级[69] - 公司将或有对价负债、或有衍生工具负债等归类为公允价值层级第3级[70,71,72,75] - 公司使用蒙特卡罗模拟法估算或有对价负债和私募配售认股权证负债的公允价值[79,83] - 公司使用"有与无"方法估算或有衍生工具负债的公允价值[84,85] - 公司的物业、厂房及设备净值为2,482万美元[90] - 公司于2024年6月30日和2023年6月30日分别计提1.3百万美元和2.5百万美元的折旧费用，以及1.5百万美元和3.0百万美元的折旧费用[91] - 截至2024年6月30日和2023年12月31日，应计费用分别为895万美元和934万美元[93] - 公司评估认为公开交易认股权证符合权益分类条件，而私募配售认股权证不符合权益分类条件，因此将其确认为衍生工具负债[126][128] - 公司采用Black-Scholes模型确定股权激励的公允价值，并根据服务期和业绩条件确认相关股份支付费用[140][141] - 公司于2024年6月30日的未认列股票报酬成本为2040万美元，预计将在未来3.0年内确认[151] - 公司于2024年6月30日的已授予但未行权的期权总数为12,521,655份，加权平均行权价格为4.89美元，加权平均剩余合同期限为8.1年[153] - 公司于2024年6月30日的已行权且可行权的期权数量为4,418,097份，加权平均行权价格为7.21美元，加权平均剩余合同期限为5.9年[153] - 公司于2024年6月30日的已授予且预计将行权的期权总数为12,521,655份，加权平均行权价格为4.89美元，加权平均剩余合同期限为8.1年[153] - 公司于2024年6月30日的普通股公允价值是根据纳斯达克交易所的收盘价确定的[145] - 公司期权的预期波动率是基于公司自身历史股价波动和同行业公司的历史股价波动的加权平均确定的[147] - 公司期权的无风险利率是基于与期权预期期限相似的美国国债收益率确定的[148] - 公司目前没有支付股利的计划，因此预期股利率为0%[149] 其他重要事项 - 公司发行股票导致额外股本2,000万股[26] - 公司确认公允价值变动损失3,016.4万美元[23] - 公司确认利息费用433.1万美元[23] - 公司确认股份支付费用289.1万美元[26][27] - 公司于2021年8月完成了与AHAC的反向重组交易[38] - 公司于2023年12月向FDA提交了用于紧急动脉修复的生物医用产品上市申请，并根据许可协议支付了50万美元的里程碑费用[161] - 公司于2023年4月和2024年5月分别获得了JDRF提供的80千美元和240千美元的研发里程碑付款[170] - 公司确定JDRF实际奖励付款应根据ASC 470归类为长期债务[171] - 公司与JDRF签订协议,同意支付一次性特许权使用费和额外特许权使用费[172][173] - JDRF协议在公司支付所有特许权