HOPE-Neuron启动投资轮，为首项非药物ALS治疗人体试验筹资

Phoenix, Arizona, Sept. 18, 2026 (GLOBE NEWSWIRE) -- HOPE-Neuron Therapeutx, Inc., a late-stage medical therapeutic company, today announced that it has opened a Regulation Crowdfunding investment round on Republic to fund the first human amyotrophic lateral sclerosis (ALS) trial of SELtx, a device-enabled process that treats a patient's own blood rather than utilizing drugs or chemicals.

亚利桑那州凤凰城，2026年9月18日（GLOBE NEWSWIRE）——处于后期开发阶段的医疗治疗公司HOPE-Neuron Therapeutx, Inc.今日宣布，已在Republic平台启动一轮Regulation Crowdfunding投资，以资助SELtx的首项人体肌萎缩侧索硬化症（ALS）试验。SELtx是一种由设备实现的治疗流程，通过处理患者自身血液进行治疗，而不使用药物或化学品。

Historically, every therapy approved for ALS has been pharmaceutical, with limited effectiveness in terms of improving and prolonging a patient’s life. HOPE-Neuron’s therapy utilizes a closed-loop, sterile process that conditions a patient’s blood to promote homeostasis, switching cells from damaging to healing mode. In a transgenic ALS mouse study, subjects treated with the company's process preserved significantly more motor function than untreated animals. Researchers confirmed the intended shift in immune cell state at p < 0.008. While the process has shown promising results in vitro and in transgenic ALS mouse studies, the next step is to test the device and define dosing in humans.

从历史上看，所有获批用于ALS的疗法都是药物疗法，在改善和延长患者生命方面疗效有限。HOPE-Neuron的疗法采用封闭式无菌流程处理患者血液，以促进稳态，使细胞从损伤模式转变为修复模式。在一项转基因ALS小鼠研究中，接受该公司流程治疗的受试动物保留的运动功能显著多于未接受治疗的动物。研究人员证实，免疫细胞状态发生了预期转变，p < 0.008。虽然该流程在体外研究和转基因ALS小鼠研究中显示出可喜结果，但下一步是在人体中测试该设备并确定剂量。

The company's founder, neurobiologist Ronald Lane, began the work after his wife was diagnosed with Alzheimer's disease. Dr. Lane, along with family and friends, has invested more than $1 million in the decade-long research that produced the technology. No outside investor had been asked to participate until now.

该公司创始人、神经生物学家Ronald Lane在妻子被诊断患有阿尔茨海默病后开始了这项工作。Lane博士与家人和朋友已在这项历时十年、最终开发出该技术的研究中投入超过$1 million。此前从未邀请过外部投资者参与。

“Our company operates with a sense of urgency that comes from true empathy for the patients we aim to help, ” said Ronald Lane, founder of HOPE-Neuron. “We’ve achieved amazing results through the dedication of a small group of supporters and team members, but now the time has come to build an investor base that can fund the next stage of our research. Every human trial is pivotal in terms of its targeted disease state, but our upcoming study is particularly important because it has the potential to open other therapeutic doorways beyond ALS.”

HOPE-Neuron创始人Ronald Lane表示：“我们公司怀着紧迫感开展工作，这种紧迫感源自对我们希望帮助的患者真正的同理心。凭借一小群支持者和团队成员的奉献，我们取得了令人惊叹的成果；但现在是建立投资者基础、为下一阶段研究提供资金的时候了。就其所针对的疾病状态而言，每一项人体试验都至关重要，而我们即将开展的研究尤为重要，因为它有可能为ALS以外的其他治疗领域打开大门。”

The capital is earmarked for three steps in sequence. The first dollars go to a medical equipment manufacturing partner in New Jersey to build the human version of the device. The company then activates the institutional review board (IRB) process with its clinical partners, and doses its first human ALS patients. HOPE-Neuron expects human test results within 12 months after funding. In terms of risk, the company is pre-revenue, has no approved product, and cautions that study results may differ from expectations.

这笔资金已指定依次用于三个步骤。首批资金将提供给新泽西州的一家医疗设备制造合作伙伴，用于制造该设备的人体应用版本。随后，公司将与临床合作伙伴启动机构审查委员会（IRB）流程，并为首批人类ALS患者实施治疗。HOPE-Neuron预计将在获得资金后的12个月内取得人体测试结果。在风险方面，该公司尚未产生收入，没有获批产品，并提醒研究结果可能与预期不同。

ALS affects roughly 34,000 Americans, who have few treatment options. The leading approved drug for ALS extends median survival by about seven months, and the most recently approved drug only targets 2% of the ALS population. The Office of Health Economics estimates that healthcare spending for ALS in the U.S. now tops $2.5 billion annually, placing a tremendous burden on families and healthcare providers.

ALS影响着大约34,000名美国人，而他们可选择的治疗方案很少。获批用于ALS的主要药物可将中位生存期延长约七个月，而最近获批的药物仅针对2%的ALS患者群体。Office of Health Economics估计，美国目前每年的ALS医疗保健支出已超过$2.5 billion，给家庭和医疗服务提供者带来沉重负担。

“Even after more than $2 billion spent on research over the last decade, an ALS diagnosis today means only 2-5 years of remaining life for a patient,” said Mark Forney of HOPE-Neuron. “We know two things about our technology that are compelling: it is different from anything else that has been tried before, and the ALS-transgenic mice we treated not only lived, but thrived. Now we are calling on the ALS community and impact investors to help fund this same therapy in humans.”

HOPE-Neuron的Mark Forney表示：“即使过去十年已投入超过$2 billion用于研究，如今确诊ALS仍意味着患者仅剩2-5年的生命。关于我们的技术，有两点极具说服力：它不同于以往尝试过的任何方法；我们治疗的ALS转基因小鼠不仅存活了下来，而且状态良好。现在，我们呼吁ALS社群和影响力投资者帮助资助将这一疗法应用于人类。”

Preclinical work was led by Dr. Yansheng Du, Professor of Neurology at Indiana University School of Medicine, who will conduct follow-on work targeting Alzheimer’s. Human clinical trial planning for ALS is underway with the Gregory W. Fulton ALS and Neuromuscular Disease Center in Phoenix, Arizona. The underlying process is protected by granted patents running to 2039.

临床前工作由Indiana University School of Medicine神经病学教授Yansheng Du博士领导，他还将开展针对阿尔茨海默病的后续研究。针对ALS的人体临床试验正在与亚利桑那州凤凰城的Gregory W. Fulton ALS and Neuromuscular Disease Center共同筹划。相关基础流程受到已授权专利的保护，专利有效期至2039年。

HOPE-Neuron will host a live investor session on Tuesday, October 6 at 11:00 a.m. Pacific, where Lane and Forney will present the company's work and take questions. Registration is free and open at https://us06web.zoom.us/webinar/register/WN_qXObscFkT6S_jl18H2AabQ.

HOPE-Neuron将于10月6日星期二太平洋时间上午11:00举行投资者直播会议，届时Lane和Forney将介绍公司的工作并回答问题。会议可免费注册，注册链接为https://us06web.zoom.us/webinar/register/WN_qXObscFkT6S_jl18H2AabQ。

The full offering, including risk factors, is available at republic.com/hope-neuron.

完整的发行资料（包括风险因素）可在republic.com/hope-neuron查阅。

HOPE-Neuron’s primary technology is SELtx™, a novel therapeutic platform that conditions a patient’s blood via mechanotransduction and precision-controlled hyperoxia to signal an apoptotic process, which generates an immune equilibrium by shifting M1 “killer” cells to M2 “healer” cells. To date, this treatment has only been administered in human ALS gene-transfected mice, though human trials are planned employing proceeds from the current offering. The proof-of-concept mouse trial was successful in slowing disease progression. The distinguishing feature of SELtx™ is that it facilitates healing via a patient’s own immune system -- without the use of infused reactive drugs or chemicals. The Company’s initial area of focus is on neurodegenerative disorders, with ALS (Lou Gehrig's disease) as the first target.

HOPE-Neuron的核心技术是SELtx™，这是一种新型治疗平台，通过机械转导和精确控制的高氧条件处理患者血液，以发出启动细胞凋亡过程的信号；该过程通过将M1“杀伤型”细胞转变为M2“修复型”细胞来建立免疫平衡。迄今为止，这种治疗仅在转染人类ALS基因的小鼠中实施过，但公司计划利用本次发行所得资金开展人体试验。概念验证小鼠试验成功减缓了疾病进展。SELtx™的显著特点是，它通过患者自身的免疫系统促进修复，而不使用输注的反应性药物或化学品。公司最初的重点领域是神经退行性疾病，并将ALS（Lou Gehrig病）作为首个目标。

More at hopeneuron.com.

更多信息请访问hopeneuron.com。

Important disclosures

重要披露

HOPE-Neuron Therapeutx, Inc. is conducting an offering under Regulation Crowdfunding through Republic. This communication does not constitute an offer to sell or a solicitation of an offer to buy any security. Any offer is made only through the company's offering statement filed with the U.S. Securities and Exchange Commission, which should be read in full, including its risk factors, before making any investment decision. Investing in early-stage companies involves substantial risk, including the loss of an investor's entire investment.

HOPE-Neuron Therapeutx, Inc.正通过Republic依据Regulation Crowdfunding开展证券发行。本通讯不构成出售任何证券的要约，也不构成购买任何证券的要约邀请。任何要约仅通过该公司向U.S. Securities and Exchange Commission提交的发行说明书作出；在作出任何投资决定之前，应完整阅读该说明书，包括其中的风险因素。投资早期公司涉及重大风险，包括投资者损失全部投资的风险。

Preclinical results described in this release are from ALS-model mice and are not human clinical results. Statements regarding the company's plans, timelines and expectations are forward-looking statements that involve risks and uncertainties. Actual outcomes may differ materially. The company undertakes no obligation to update any forward-looking statement.

本新闻稿所述临床前结果来自ALS模型小鼠，并非人体临床结果。有关公司计划、时间表和预期的陈述属于涉及风险和不确定性的前瞻性陈述。实际结果可能存在重大差异。公司不承担更新任何前瞻性陈述的义务。

Mark Forney Vice President of Business Development HOPE-Neuron Therapeutx 305-239-7657 ​​hope@hopeneuron.com

Mark Forney 业务发展副总裁 HOPE-Neuron Therapeutx 305-239-7657 hope@hopeneuron.com