<p><strong>Humacyte Inc.</strong> (NASDAQ: HUMA) 股票在周四大幅下跌，尽管报告了其无细胞组织工程血管（ATEV）的积极中期三期数据，但投资者关注的是与临床更新同时宣布的严重稀释的股票发行。</p>
<p>周三，Humacyte 发布了针对女性透析患者的无细胞组织工程血管（ATEV）的中期三期结果。</p>
<p>ATEV 是一种源自培养人类细胞的生物工程人类组织，旨在作为一种可普遍植入的血管导管，用于血管替代和修复。</p>
<h2>三期试验达到主要终点</h2>
<p>该生物技术公司表示，其三期 V012 研究中首批 80 名患者的 预先指定的中期分析 达到了试验的主要终点。</p>
<p>接受 ATEV 治疗的患者记录了平均 220 天无导管使用的天数，而接受自体动静脉（AV）瘘管治疗的患者则为 129 天，这是当前的标准治疗。</p>
<p>91 天的改善具有统计学意义，p 值为 0.00070。</p>
<p><strong>另请阅读：</strong>
<strong>Incyte 在具有潜在爆款的罕见出血疾病药物上押注 12.5 亿美元</strong></p>
<h2>安全性概况保持良好</h2>
<p>根据公司数据，接受 ATEV 治疗的患者感染发生率为每 100 患者年 6 例，而接受 AV 瘘管治疗的患者为每 100 患者年 23 例。</p>
<p>在 ATEV 接受者中未报告任何与通路相关的感染，而 AV 瘘管组则发生了三例。研究人员还报告在任何治疗组中均未出现自发性破裂，并表示在分析过程中没有出现新的或意外的安全问题。</p>
<p>根据研究协议， enrollment 将在主要终点达到后提前结束，而已入组患者将 继续接受监测。</p>
<p>Humacyte 计划在 2026 年下半年向 FDA 提交补充生物制品许可申请。</p>
<p>拟议的适应症针对面临 AV 瘘管成熟失败风险的终末期肾病成人。</p>
<h2>发行以资助商业化和开发</h2>
<p>另外，Humacyte 将其 4760 万股普通股的承销公开发行定价为每股 1.05 美元，预计产生约 5000 万美元的毛收入。</p>
<p>公司还授予承销商购买最多 额外 710 万股 的选择权。</p>
<p>Humacyte 将利用这些收益支持 Symvess 的商业化，为计划中的与血液透析相关的 BLA 补充申请做准备，推进管道项目，并资助一般企业活动。</p>
<p><strong>HUMA 股票价格活动</strong>：根据 Benzinga Pro 数据，Humacyte 股价在周四发布时下跌 22.76%，报 1.03 美元。</p>
<p><em>图片来源于 Shutterstock</em></p>
<p><strong>另请阅读：</strong>
<strong>交易减少，风险加大：并购趋势与股市相呼应</strong></p>

HUMA

<p>Humacyte (HUMA) 的股票下跌了 22%，尽管其 ATEV 产品的第三阶段试验数据表现积极，达到了主要终点并带来了显著的临床益处。此次下跌主要是由于一项稀释性的 5000 万美元公开发行，发行价格为每股 1.05 美元，用于资助商业化和开发</p>

<p><strong>Humacyte Inc.</strong> (NASDAQ: HUMA) stock plunged Thursday despite reporting positive interim Phase 3 data for its acellular tissue-engineered vessel (ATEV), as investors focused on a heavily dilutive stock offering announced alongside the clinical update.</p>
<div class="lb-trans"><p><strong>Humacyte Inc.</strong> (NASDAQ: HUMA) 股票在周四大幅下跌，尽管报告了其无细胞组织工程血管（ATEV）的积极中期三期数据，但投资者关注的是与临床更新同时宣布的严重稀释的股票发行。</p>
</div><p>On Wednesday, Humacyte released interim Phase 3 results for its acellular tissue-engineered vessel (ATEV) in female dialysis patients.</p>
<div class="lb-trans"><p>周三，Humacyte 发布了针对女性透析患者的无细胞组织工程血管（ATEV）的中期三期结果。</p>
</div><p>ATEV is a bioengineered human tissue derived from cultured human cells that is designed to be a universally implantable vascular conduit for use in vascular replacement and repair.</p>
<div class="lb-trans"><p>ATEV 是一种源自培养人类细胞的生物工程人类组织，旨在作为一种可普遍植入的血管导管，用于血管替代和修复。</p>
</div><h2>Phase 3 Trial Meets Primary Endpoint</h2>
<div class="lb-trans"><h2>三期试验达到主要终点</h2>
</div><p>The biotechnology company said a prespecified interim analysis of the first 80 patients enrolled in its Phase 3 V012 study met the trial’s primary endpoint.</p>
<div class="lb-trans"><p>该生物技术公司表示，其三期 V012 研究中首批 80 名患者的 预先指定的中期分析 达到了试验的主要终点。</p>
</div><p>Patients treated with the ATEV recorded an average of 220 catheter-free days, compared with 129 days for those receiving an autologous arteriovenous (AV) fistula, the current standard of care.</p>
<div class="lb-trans"><p>接受 ATEV 治疗的患者记录了平均 220 天无导管使用的天数，而接受自体动静脉（AV）瘘管治疗的患者则为 129 天，这是当前的标准治疗。</p>
</div><p>The 91-day improvement was statistically significant, with a p-value of 0.00070.</p>
<div class="lb-trans"><p>91 天的改善具有统计学意义，p 值为 0.00070。</p>
</div><p><strong>Read Also:</strong>
<strong>Incyte Bets $1.25 Billion On Rare Bleeding Disorder Drug With Blockbuster Potential</strong></p>
<div class="lb-trans"><p><strong>另请阅读：</strong>
<strong>Incyte 在具有潜在爆款的罕见出血疾病药物上押注 12.5 亿美元</strong></p>
</div><h2>Safety Profile Remains Favorable</h2>
<div class="lb-trans"><h2>安全性概况保持良好</h2>
</div><p>According to the company, patients receiving the ATEV experienced infections at a rate of six per 100 patient-years, compared with 23 per 100 patient-years among patients receiving AV fistulas.</p>
<div class="lb-trans"><p>根据公司数据，接受 ATEV 治疗的患者感染发生率为每 100 患者年 6 例，而接受 AV 瘘管治疗的患者为每 100 患者年 23 例。</p>
</div><p>No access-related infections were reported among ATEV recipients, while three occurred in the AV fistula group. Researchers also reported no spontaneous ruptures in either treatment arm and said no new or unexpected safety concerns emerged during the analysis.</p>
<div class="lb-trans"><p>在 ATEV 接受者中未报告任何与通路相关的感染，而 AV 瘘管组则发生了三例。研究人员还报告在任何治疗组中均未出现自发性破裂，并表示在分析过程中没有出现新的或意外的安全问题。</p>
</div><p>Under the study protocol, enrollment will now end early after the primary endpoint is achieved, while enrolled patients will continue to be monitored.</p>
<div class="lb-trans"><p>根据研究协议， enrollment 将在主要终点达到后提前结束，而已入组患者将 继续接受监测。</p>
</div><p>Humacyte plans to submit a supplemental Biologics License Application to the FDA in the second half of 2026.</p>
<div class="lb-trans"><p>Humacyte 计划在 2026 年下半年向 FDA 提交补充生物制品许可申请。</p>
</div><p>The proposed indication targets adults with end-stage kidney disease who face an elevated risk of AV fistula maturation failure.</p>
<div class="lb-trans"><p>拟议的适应症针对面临 AV 瘘管成熟失败风险的终末期肾病成人。</p>
</div><h2>Offering To Fund Commercialization And Development</h2>
<div class="lb-trans"><h2>发行以资助商业化和开发</h2>
</div><p>Separately, Humacyte priced its underwritten public offering of 47.6 million shares of common stock at $1.05 per share, generating expected gross proceeds of approximately $50 million.</p>
<div class="lb-trans"><p>另外，Humacyte 将其 4760 万股普通股的承销公开发行定价为每股 1.05 美元，预计产生约 5000 万美元的毛收入。</p>
</div><p>The company also granted underwriters an option to purchase up to an additional 7.1 million shares.</p>
<div class="lb-trans"><p>公司还授予承销商购买最多 额外 710 万股 的选择权。</p>
</div><p>Humacyte will use the proceeds to support the commercialization of Symvess, prepare for the planned hemodialysis-related BLA supplement filing, advance pipeline programs, and fund general corporate activities.</p>
<div class="lb-trans"><p>Humacyte 将利用这些收益支持 Symvess 的商业化，为计划中的与血液透析相关的 BLA 补充申请做准备，推进管道项目，并资助一般企业活动。</p>
</div><p><strong>HUMA Stock Price Activity</strong>: Humacyte shares were down 22.76% at $1.03 at the time of publication on Thursday, according to Benzinga Pro data.</p>
<div class="lb-trans"><p><strong>HUMA 股票价格活动</strong>：根据 Benzinga Pro 数据，Humacyte 股价在周四发布时下跌 22.76%，报 1.03 美元。</p>
</div><p><em>Photo via Shutterstock</em></p>
<div class="lb-trans"><p><em>图片来源于 Shutterstock</em></p>
</div><p><strong>Read Also:</strong>
<strong>Fewer Deals, Higher Stakes: M&amp;A Trend Is Mirroring The Equity Market</strong></p>
<div class="lb-trans"><p><strong>另请阅读：</strong>
<strong>交易减少，风险加大：并购趋势与股市相呼应</strong></p>
</div>

为什么 Humacyte 的股票在周四下跌？