The planned interim analysis confirms the accuracy of the sample size calculations and statistical power for EMACC, the primary endpoint.

计划的中期分析证实了样本量计算的准确性和主要终点EMACC的统计能力。

The interim analysis, performed by a third-party, demonstrated no need to change trial design or size.

由第三方进行的中期分析表明，没有必要改变试验设计或规模。

BOCA RATON, Fla., June 27, 2024 (GLOBE NEWSWIRE) --  INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today confirmed the Phase II Alzheimer’s Disease clinical trial, AD02, is appropriately powered following a blinded sample size re-estimation using the trial’s primary endpoint, the Early Mild Alzheimer’s Cognitive Composite (EMACC).

佛罗里达州博卡拉顿（BOCA RATON），2024年6月27日（Global NEWSWIRE）--INmune Bio Inc.（纳斯达克：INMB）（“公司”）是一家临床阶段免疫学公司，专注于开发利用患者先天免疫系统对抗疾病的治疗方法，今天证实了II期阿尔茨海默病临床试验AD02在使用试验的主要终点早期轻度阿尔茨海默病认知复合物（EMACC）进行盲法样本量重新估计后得到了适当的支持。

The third-party evaluation concluded that the trial design, operational execution, data collection, and management are of the highest quality..

第三方评估得出的结论是，试验设计，操作执行，数据收集和管理都是最高质量的。。

INmune Bio commissioned a third-party group of statisticians and neuropsychologists to evaluate the interim data of patients who completed the 6-month trial. The main goal of the blinded analysis was to evaluate the power and performance characteristics of the primary endpoint, the EMACC.

INmune Bio委托第三方统计学家和神经心理学家小组评估完成6个月试验的患者的中期数据。盲法分析的主要目的是评估主要终点EMACC的功效和性能特征。

The EMACC is an empirically validated cognitive measure composed of standardized and widely used neuropsychological tests that are ideally suited for use in clinical trials in Early Alzheimer’s Disease (AD). Compared to CDR-SB and ADAS-Cog for example, the EMACC is an objective measure of cognitive function that accurately captures cognitive changes that occur during early AD.

EMACC是一种经过经验验证的认知测量方法，由标准化和广泛使用的神经心理学测试组成，非常适合用于早期阿尔茨海默病（AD）的临床试验。例如，与CDR-SB和ADAS-Cog相比，EMACC是一种客观的认知功能测量方法，可以准确地捕捉AD早期发生的认知变化。

The performance characteristics of the EMACC in early AD were first reported by Biogen at CTAD in 2021 (LBR05) where it was successfully applied to measure cognitive decline in the Biogen Tango Study of the gosenuremab program (BIIB092). Notably, EMACC was also  found to be strongly associated with biological markers of inflammation in the Alzheimer’s Diesase Neuroimaging Initiative (ADNI) AD study; which was used to compute the statistical power for AD02. .

2021年，Biogen在CTAD（LBR05）首次报道了AD早期EMACC的表现特征，并成功应用于测量gosenuremab计划（BIIB092）的Biogen探戈研究中的认知衰退。值得注意的是，在阿尔茨海默病神经影像学倡议（ADNI）AD研究中，还发现EMACC与炎症的生物标志物密切相关；用于计算AD02的统计功效。

“As this is the first trial to feature the EMACC as a primary endpoint, this interim analysis by a third party was critical to ensure that the EMACC is performing as intended,” says CJ Barnum, PhD, VP of Neuroscience at INmune Bio. “The results presented to the Company from this blinded analysis were extremely encouraging.”.

INmune Bio神经科学副总裁CJ Barnum博士说：“由于这是第一次将EMACC作为主要终点的试验，因此第三方的中期分析对于确保EMACC按预期运行至关重要。”这项盲法分析向该公司提供的结果非常令人鼓舞。”。

“As a neuropsychologist that has worked in industry for more than three decades, it is refreshing to work with a company that uses a data driven approach to cognitive testing,” said Paul Maruff PhD, a senior consultant on the AD02 program. “Unlike the anti-amyloid therapies, XPro™ targets inflammation, a completely different mechanism.

AD02项目高级顾问保罗·马鲁夫博士（PaulMaruff PhD）表示：“作为一名在业界工作了三十多年的神经心理学家，与一家使用数据驱动方法进行认知测试的公司合作令人耳目一新。”。“与抗淀粉样蛋白疗法不同，XPro™靶向炎症，这是一种完全不同的机制。

We should not expect that the same cognitive test will work for all mechanisms. INmune Bio’s approach optimizes the measurement of cognition for a therapy that targets inflammation. As part of a scientific committee reviewing data from the first interim analyses, I was reassured to see the very low rates of missing data in the study, which indicate that the EMACC has high acceptability in the symptomatic AD sample enrolled to date.

我们不应该期望相同的认知测试适用于所有机制。INmune Bio的方法优化了针对炎症的治疗的认知测量。作为审查第一次中期分析数据的科学委员会的一部分，我很放心地看到研究中缺失数据的比率非常低，这表明EMACC在迄今为止登记的症状性AD样本中具有很高的可接受性。

Furthermore, estimates of group means and standard deviations, computed on the blinded data from AD02, showed these estimates to be consistent with those used for planning the trial, confirming that assumptions made during planning are being met in the conduct of the trial itself.”.

此外，根据AD02的盲法数据计算出的组均值和标准差估计值显示，这些估计值与用于计划试验的估计值一致，证实了在计划期间做出的假设在试验本身的进行中得到了满足。”。

Dr. Judith Jeager PhD, the neuropsychologist that worked closely with INmune Bio to identify the most appropriate cognitive test to evaluate XPro™ was similarly pleased with the result of the interim analysis: “We believe the EMACC is the optimal tool for detecting cognitive change and differentiating an effective drug from placebo in inflamed patients with early AD.

。

This interim analysis confirmed once again its excellent suitability for this population as indicated by normally distributed data, paucity of outliers and absence of floor and ceiling effects. The blinded review of EMACC’s critical psychometric parameters exceed my expectations and reinforces that the EMACC is the appropriate test to measure cognition in INmune Bio’s AD02 clinical trial.”  .

这项中期分析再次证实了它对这一人群的极好适用性，如正态分布的数据，异常值的缺乏以及没有地板和天花板效应所表明的。对EMACC关键心理测量参数的盲法审查超出了我的预期，并强化了EMACC是在INmune Bio的AD02临床试验中测量认知的合适测试。”。

About the Expert Consultants

关于专家顾问

Paul Maruff, PhD, is the Chief Innovation Officer of Cogstate, a global leader in supporting clinical trials that use cognition as a clinical endpoint. He is recognized as a leader in testing of cognition in clinical trials with more than 30 years of experience.

保罗·马鲁夫博士是Cogstate的首席创新官，Cogstate是支持以认知为临床终点的临床试验的全球领导者。他被公认为临床试验认知测试的领导者，拥有30多年的经验。

Judith Jaeger, PhD, is the principal developer of the EMACC. Judith Jaeger PhD is founder of CognitionMetrics, a prominent neurocognition consulting firm. Dr. Jaeger is an internationally recognized expert in designing cognitive function testing programs to use in clinical trials with more than two decades’ experience.  .

JudithJaeger博士是EMACC的主要开发人员。朱迪思·杰格博士是著名神经认知咨询公司CognitionMetrics的创始人。Jaeger博士是国际公认的设计认知功能测试程序以用于临床试验的专家，拥有20多年的经验。。

About XPro™

关于XPro™

XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation.

XPro™是目前正在进行临床试验的下一代肿瘤坏死因子（TNF）抑制剂，其作用与目前可用的TNF抑制剂不同，因为它中和可溶性TNF（sTNF），而不影响跨膜TNF（tmTNF）或TNF受体。。

For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website..

有关针对大脑神经炎症以改善认知功能和恢复神经元交流的重要性的更多信息，请访问INmune Bio网站的这一部分。。

About INmune Bio Inc.

关于免疫生物公司。

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases.

INmune Bio公司。是一家上市（纳斯达克股票代码：INMB）的临床阶段生物技术公司，专注于开发针对先天免疫系统的治疗方法以对抗疾病。INmune Bio有两个产品平台都在临床试验中：显性负性肿瘤坏死因子（DN-TNF）产品平台利用显性负性技术选择性中和可溶性TNF，这是先天免疫功能障碍的关键驱动因素，也是许多疾病的机制驱动因素。

DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Early Alzheimer’s disease and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer.

DN-TNF候选产品正在进行临床试验，以确定它们是否可以治疗癌症（INB03™），早期阿尔茨海默病和难治性抑郁症（XPro™）。自然杀伤细胞引发平台包括INKmune™开发用于引发患者的NK细胞，以消除癌症患者的微小残留疾病。

INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com..

INmune Bio的产品平台利用精准医学方法治疗各种血液和实体瘤恶性肿瘤以及慢性炎症。。。

Forward-Looking Statements

前瞻性声明

Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.

临床试验处于早期阶段，无法保证会取得任何具体结果。本新闻稿中包含的任何不描述历史事实的声明可能构成前瞻性声明，因为该术语在1995年《私人证券诉讼改革法案》中有定义。

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties.

本新闻稿中包含的任何不描述历史事实的声明可能构成前瞻性声明，因为该术语在1995年《私人证券诉讼改革法案》中有定义。。

Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved.

。INB03™、XPro1595（XPro™）和INKmune™仍在进行临床试验或准备开始临床试验，尚未获得美国食品和药物管理局（FDA）或任何监管机构的批准，因此无法保证它们将获得FDA或任何监管机构的批准或取得任何具体结果。

The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies.

可能导致实际未来结果与当前预期产生重大差异的因素包括但不限于与公司生产更多临床试验药物的能力有关的风险和不确定性；该公司有大量额外资金继续运营，并进行研发、临床研究和未来产品商业化；以及公司的业务、研究、产品开发、监管批准、营销和分销计划和战略。

These and other factors are identified and described in m.

这些和其他因素在m中被识别和描述。

INmune Bio Contact:

免疫生物接触：

David Moss, CFO (858) 964-3720

David Moss，首席财务官（858）964-3720

info@inmunebio.com

info@inmunebio.com

Investor Contact:

投资者联系人：

Mike Moyer

迈克·莫耶

Managing Director – LifeSci Advisors

LifeSci Advisors董事总经理

mmoyer@lifesciadvisors.com

mmoyer@lifesciadvisors.com