Investment was led by Clene’s Chairman of the Board of Directors, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders

本轮投资由Clene公司董事会主席领衔，联合创始投资者肯辛顿资本控股（Kensington Capital Holdings）、Clene首席执行官及其他现有股东共同参与。

$4 million registered direct offering was priced at market under Nasdaq rules

400万美元的注册直接发行已按纳斯达克规则以市价定价

Proceeds are expected to be sufficient to fund the Company to mid-first quarter 2027, which is beyond the potential FDA decision to accept the CNM-Au8

预计所得款项足以支持公司运营至2027年第一季度中期，届时已超出美国食品药品监督管理局（FDA）就可能批准CNM-Au8作出决定的潜在时间点。

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NDA for review under the accelerated approval pathway

用于加速审批途径审查的新药申请

SALT LAKE CITY, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), a clinical-stage biotechnology company focused on ALS, today announced the closing of a registered direct offering of common stock to existing shareholders, including insiders, with total gross proceeds of $4 million.

盐湖城，2026年9月21日（环球电讯社）——专注于肌萎缩侧索硬化症（ALS）的临床阶段生物技术公司Clene Inc.（纳斯达克股票代码：CLNN）今日宣布，完成向现有股东（包括内部人士）进行的注册直接普通股发行，总募集资金达400万美元。

The offering was led by Clene’s Chairman of the Board of Directors, David Matlin, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders.

本次发行由Clene董事会主席David Matlin牵头，联合创始投资者Kensington Capital Holdings、Clene首席执行官及其他现有股东共同参与。

The offering was made without a placement agent, underwriter, broker or dealer, and is expected to provide Clene with sufficient cash to fund its operations through mid-first quarter 2027, which is beyond the potential U.S. Food and Drug Administration (FDA) decision for accepting the New Drug Application (NDA) for review of CNM-Au8.

本次发行未通过配售代理、承销商、经纪人或交易商进行，预计将为Clene提供充足的现金，以支持其运营至2027年第一季度中期，这一时间点晚于美国食品药品监督管理局（FDA）就可能受理CNM-Au8新药申请（NDA）进行审查所作出的潜在决定。

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for treatment of amyotrophic lateral sclerosis (ALS) under the accelerated approval pathway. In addition, if the FDA accepts the NDA from Clene for review, the Company could potentially receive $6.7 million to $7.8 million in proceeds from common stock warrants issued in a January 2026 financing that could further extend the Company’s cash runway. .

用于通过加速审批途径治疗肌萎缩侧索硬化症（ALS）。此外，如果美国食品药品监督管理局（FDA）接受Clene提交的新药申请（NDA）进行审评，公司可能从2026年1月融资中发行的普通股认股权证中获得670万至780万美元的收益，从而进一步延长公司的现金跑道。

About Clene

关于Clene

Clene Inc. (Nasdaq: CLNN), along with its subsidiaries, “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis.

Clene Inc.（纳斯达克股票代码：CLNN）及其子公司“Clene”和其全资子公司Clene Nanomedicine, Inc.是一家处于临床后期阶段的生物制药公司，专注于改善线粒体健康并保护神经元功能，以治疗包括肌萎缩侧索硬化症、帕金森病和多发性硬化症在内的神经退行性疾病。

CNM-Au8.

CNM-Au8。

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is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8

CNM-Au8 是一种处于研究阶段的首创疗法，通过靶向线粒体功能和 NAD 通路并减少氧化应激的机制，改善中枢神经系统细胞的存活与功能。

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is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit

是Clene Nanomedicine, Inc.的联邦注册商标。该公司总部位于犹他州盐湖城，研发和制造业务位于马里兰州。欲了解更多信息，请访问

www.clene.com

www.clene.com

or follow us on

或在以下平台关注我们

X

X

(formerly

（前身为

Twitter

推特

) and

) 和

LinkedIn

领英

.

。

Forward Looking Statements

前瞻性陈述

This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created by those laws. Clene’s forward-looking statements include, but are not limited to, statements regarding the timing of the Company’s NDA submission, that the biomarker findings support an NDA submission, and the timing of the initiation of the Phase 3 trial.

本新闻稿包含经修订的《1934年证券交易法》第21E条和经修订的《1933年证券法》第27A条所指的“前瞻性陈述”，这些陈述旨在受上述法律设立的“安全港”条款保护。Clene的前瞻性陈述包括但不限于，关于公司新药申请（NDA）提交时间的陈述、生物标志物研究结果支持提交新药申请的陈述，以及启动III期临床试验时间的陈述。

In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

此外，任何提及预测、预估或对未来事件或情况的其他描述（包括任何基本假设）的陈述均属于前瞻性陈述。“预期”、“相信”、“考虑”、“继续”、“估计”、“期望”、“打算”、“可能”、“或许”、“计划”、“有可能”、“潜在”、“预测”、“规划”、“应当”、“将”、“将会”等词语及类似表述可用于识别前瞻性陈述，但未出现这些词语并不意味着某项陈述不属于前瞻性陈述。

These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

这些前瞻性陈述反映了我们在本新闻稿发布之日的观点，涉及多项判断、风险和不确定性。我们预计，后续事件和发展将导致我们的观点发生变化。除适用证券法律可能要求的情况外，我们没有义务因新信息、未来事件或其他原因而更新前瞻性陈述，以反映其在作出之日后发生的事件或情况。

Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be ma.

因此，不应依赖前瞻性陈述来代表我们在任何后续日期的观点。由于存在许多已知和未知的风险与不确定性，我们的实际结果或表现可能会受到重大影响。

post hoc

事后

and exploratory nature of the biomarker analyses described in this press release, which were not prespecified, were not adjusted for multiplicity, and are based on small patient numbers, and which may not be predictive of results in future trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q.

以及本新闻稿中所述的生物标志物分析的探索性性质，这些分析并非预先指定，未对多重性进行调整，且基于少量患者数据，可能无法预测未来试验的结果；监管机构的行为，这可能会影响临床试验的启动、时间和进展以及市场批准；我们在药物候选产品获得批准的情况下实现商业成功的能力；我们有限的运营历史以及我们为运营获取额外资金并完成药物候选产品的开发和商业化的能力；以及在我们最新的10-K表格年度报告和任何后续的10-Q表格季度报告中“风险因素”部分列出的其他风险和不确定性。

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information.

此外，“我们相信”及类似表述反映了我们就相关主题所持的信念和观点。这些表述基于本新闻稿发布之日我们所掌握的信息，尽管我们认为此类信息构成了作出这些表述的合理基础，但该等信息可能是有限或不完整的，因此不应将我们的表述解读为我们已对所有可能获取的相关信息进行了详尽的调查或审查。

These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release..

这些陈述本质上具有不确定性，谨提醒您勿过度依赖这些陈述。本新闻稿中的所有信息均截至本新闻稿发布之日。本文所引用的任何网站中包含的信息均不构成、也不应被视为本新闻稿的一部分或纳入本新闻稿。

Investor Contact

投资者联系

: Kevin Gardner, LifeSci Advisors;

凯文·加德纳，LifeSci Advisors；

kgardner@lifesciadvisors.com

kgardner@lifesciadvisors.com

; 617-283-2856

; 617-283-2856

Media Contact:

媒体联系人：

Caroline Wagner, FTP;

卡罗琳·瓦格纳，FTP；

CWagner@ftpadvocacy.com

CWagner@ftpadvocacy.com

; (267) 294-6563

(267) 294-6563