CLNN

Clene expects to submit a New Drug Application for CNM-Au8® in ALS under the accelerated approval pathway in early fourth quarter of 2026 Clene announces survival and functional benefit in CNM-Au8-treated patients whose NfL declined or stabilized SALT LAKE CITY, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) today announced its second quarter 2026 financial results and provided recent updates on its CNM-Au8 programs. “We plan to submit our new drug application (NDA) for CNM-Au8 under the accelerated approval pathway for patients with ALS and believe the evidence connecting the magnitude of NfL reduction to clinical benefit data we have generated since our last FDA meeting will be critical for a successful review,” said Rob Etherington, President and CEO of Clene. “Patients with ALS are in desperate need of additional treatment options, and we believe that CNM-Au8 may restore and protect neuronal health and function, leading to improved survival.” Second Quarter 2026 and Recent Operating Highlights CNM-Au8 for the treatment of ALS Clene announced receipt of formal meeting minutes in May, confirming the Company's ability to file an NDA for CNM-Au8 for the treatment of ALS under the accelerated approval pathway. In its final meeting minutes, the U.S. Food and Drug Administration (FDA), stated that Clene's “proposed data may be capable of supporting the submission and review of an NDA under the accelerated approval pathway for the treatment of ALS.” The FDA reminded the Company that the submission should demonstrate the effectiveness of and effect of CNM-Au8 on neurofilament light (NfL) and show that the magnitude of change in NfL is reasonably likely to predict clinical benefits in patents with ALS. New biomarker analyses of the Company’s two completed Phase 2 ALS trials revealed additional evidence that CNM-Au8-treated patients whose NfL declined or stabilized lived significantly longer than concurrently randomized controls and performed significantly better on combined measures of survival and function, including the ALS Functional Rating Scale-Revised (ALSFRS-R) and breathing capacity (Slow Vital Capacity; SVC). These new data intend to show the FDA that the “magnitude of change in NfL is reasonably likely to predict clinical benefits in patients with ALS,” as noted from the FDA minutes. These findings were derived from multiple lines of analysis: clinical benefit versus concurrently randomized controls; the relationship between the size of the NfL reduction and clinical outcome; a causal analysis that identified likely NfL responders from pre-treatment characteristics alone, preserving the randomized comparison; and replication of the association between NfL change and survival across independent datasets. The NDA submission is expected to be made under the accelerated approval pathway and will be supported by NfL biomarker and clinical data from the Phase 2 HEALEY ALS Platform Trial and its open-label extension, the Phase 2 RESCUE-ALS Trial, and the NIH-sponsored Expanded Access Protocol for CNM-Au8. Corporate UpdateIn May, the Company closed an underwritten registered direct common stock offering to a single investor totaling $7.0 million in gross proceeds. Also in May, the Company amended its existing $10.0 million senior secured convertible debt facility and its $1.5 million senior secured convertible debt facility to extend the maturity date of both senior secured convertible debt facilities to August 2027 and to eliminate any required principal and interest payments prior to maturity in August 2027. Second Quarter 2026 Financial ResultsClene's cash and cash equivalents totaled $9.7 million as of June 30, 2026, compared to $5.2 million as of December 31, 2025. Net cash used in operating activities was $7.1 million for the six months ended June 30, 2026, compared to $9.8 million for the same period in 2025. Clene expects that its resources as of June 30, 2026, will provide operating runway through late fourth quarter 2026. Research and development expenses were $3.5 million for the quarter ended June 30, 2026, compared to $3.5 million for the same period in 2025. The changes were primarily attributable to lower expenses related to the Company's ALS expanded access programs (EAPs) and planning activities for the RESTORE-ALS clinical trial, and lower expenses related to our REPAIR-MS clinical trial program due to its conclusion, partially offset by an increase in expenses for regulatory activities related to the Company's ongoing FDA discussions and preparation of its planned NDA submission and expenses related to our MS EAP, as well as higher pre-clinical, manufacturing and personnel related expenses. General and administrative expenses were $1.9 million for the quarter ended June 30, 2026, compared to $2.4 million for the same period in 2025. The decrease was primarily attributable to lower legal fees and finance and accounting fees, as well as decreased stock-based compensation expenses and an increase in grant revenue recorded as a reduction to general and administrative expense. Total other expense, net, was $8.1 million for the quarter ended June 30, 2026, compared to $1.6 million for the same period in 2025. The year-over-year increase was primarily attributable to a change in fair value of common stock warrant liabilities and derivative liabilities and higher interest expense related to the Company's outstanding $1.5 million senior secured convertible note issued in August 2025. Clene reported a net loss of $13.4 million, or $1.08 per share, for the quarter ended June 30, 2026, compared to a net loss of $7.4 million, or $0.78 per share, for the same period in 2025. About CleneClene 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. CNM-Au8® 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® 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 www.clene.com or follow us on X (formerly Twitter) and LinkedIn. About CNM-Au8®CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. Forward-Looking Statements 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 meeting with the FDA, the timing of the Company’s NDA submission, and that the biomarker findings support an NDA submission. 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. 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. 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 materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; 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. 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. 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. Investor Contact: Kevin Gardner, LifeSci Advisors; [email protected]; 617-283-2856Media Contact: Caroline Wagner, FTP; [email protected]; (267) 294-6563

In the last week, the United States market has stayed flat, yet it has seen a remarkable 25% increase over the past year with earnings forecasted to grow by 17% annually. In this thriving environment, growth companies with high insider ownership can be particularly appealing as they often indicate strong confidence from those closest to the business in its potential for continued success. Click here to see the full list of 187 stocks from our Fast Growing US Companies With High Insider Ownership screener. Below we spotlight a couple of our favorites from our exclusive screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Aeluma, Inc. develops optoelectronic and electronic devices for sensing, communication, and computing applications in the United States with a market cap of $488.06 million. Operations: The company's revenue is primarily derived from its Semiconductor Equipment and Services segment, which generated $5.23 million. Insider Ownership: 25.8% Earnings Growth Forecast: 68.6% p.a. Aeluma is positioned for significant growth with forecasted revenue expansion of 77% annually, outpacing the US market. Despite a volatile share price and recent net losses, its strategic focus on high-growth sectors like AI infrastructure and quantum technologies is bolstered by substantial U.S. government contracts exceeding US$4 million. The company's innovative quantum dot laser platform, supported by NASA awards, enhances its competitive edge in photonics integration. However, low projected return on equity remains a concern. Click to explore a detailed breakdown of our findings in Aeluma's earnings growth report. Our valuation report here indicates Aeluma may be overvalued. Simply Wall St Growth Rating: ★★★★☆☆ Overview: STAAR Surgical Company designs, develops, manufactures, and sells phakic implantable lenses and accessory delivery systems for the eye, with a market cap of approximately $1.40 billion. Operations: The company's revenue is primarily generated from its ophthalmic surgical products, totaling $239.44 million. Insider Ownership: 26.2% Earnings Growth Forecast: 71.6% p.a. STAAR Surgical's growth potential is underscored by its forecasted revenue increase of 11.8% annually, slightly above the US market average. Recent earnings showed significant improvement with sales reaching US$93.52 million, a substantial rise from the previous year, and a shift to net income of US$5.21 million from a prior loss. The recent FDA approval expanding age indications for its EVO ICL product enhances market reach, supporting long-term growth prospects despite past financial volatility. Dive into the specifics of STAAR Surgical here with our thorough growth forecast report. Insights from our recent valuation report point to the potential overvaluation of STAAR Surgical shares in the market. Simply Wall St Growth Rating: ★★★★★☆ Overview: Hyliion Holdings Corp. designs and develops power generators for stationary and mobile applications, with a market cap of approximately $477.92 million. Operations: Hyliion Holdings Corp. focuses on the design and development of power generators for both stationary and mobile applications, although specific revenue segments are not detailed in the provided information. Insider Ownership: 22.5% Earnings Growth Forecast: 54.3% p.a. Hyliion Holdings shows promising growth potential, with revenue expected to rise 75.2% annually, significantly outpacing the US market. Recent earnings reveal a substantial increase in revenue to US$2.83 million, though net losses persist at US$11.74 million. The successful demonstration of its KARNO reactor's multi-fuel capability highlights technological advancements that could drive future sales and market expansion. Despite financial volatility and limited cash runway, Hyliion's innovative approach supports its growth trajectory in diverse applications. Unlock comprehensive insights into our analysis of Hyliion Holdings stock in this growth report. Our comprehensive valuation report raises the possibility that Hyliion Holdings is priced higher than what may be justified by its financials. Navigate through the entire inventory of 187 Fast Growing US Companies With High Insider Ownership here. Contemplating Other Strategies? The best AI stocks today may lie beyond giants like Nvidia and Microsoft. Find the next big opportunity with these 16 smaller AI-focused companies with strong growth potential through early-stage innovation in machine learning, automation, and data intelligence that could fund your retirement. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.The analysis only considers stock directly held by insiders. It does not include indirectly owned stock through other vehicles such as corporate and/or trust entities. All forecast revenue and earnings growth rates quoted are in terms of annualised (per annum) growth rates over 1-3 years. Companies discussed in this article include ALMU STAA and HYLN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Over the last 7 days, the United States market has risen by 1.1%, contributing to an impressive 27% climb over the past year, with earnings forecasted to grow by 17% annually. In this thriving environment, companies that exhibit high growth potential and significant insider ownership can be particularly appealing, as they often indicate strong confidence from those closest to the business. Click here to see the full list of 181 stocks from our Fast Growing US Companies With High Insider Ownership screener. Let's take a closer look at a couple of our picks from the screened companies. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Evolus, Inc. is a performance beauty company that provides products in the cash-pay aesthetic market across the United States, Canada, Europe, and Australia with a market cap of $442.54 million. Operations: The company's revenue segment focuses on delivering medical aesthetic products to the cash-pay aesthetic market, generating $301.79 million. Insider Ownership: 11.1% Earnings Growth Forecast: 66.7% p.a. Evolus, Inc. is poised for significant growth with its forecasted profitability within three years and revenue growth expected to outpace the broader US market at 14.4% annually. Recent earnings show a narrowing net loss, and the company anticipates annual revenues between US$327 million and US$337 million for 2026. The upcoming European launch of Estyme marks an international expansion in dermal fillers, potentially enhancing revenue streams despite historically volatile share prices and negative shareholders' equity concerns. Click here and access our complete growth analysis report to understand the dynamics of Evolus. Our expertly prepared valuation report Evolus implies its share price may be lower than expected. Simply Wall St Growth Rating: ★★★★★★ Overview: Upstart Holdings, Inc. operates a cloud-based AI lending platform in the United States and has a market cap of approximately $2.58 billion. Operations: The company's revenue is primarily derived from its personal lending segment, which generated $1.01 billion. Insider Ownership: 12.8% Earnings Growth Forecast: 58.5% p.a. Upstart Holdings is positioned for robust growth, with earnings projected to rise significantly at 58.5% annually, outpacing the US market. Despite a recent net loss of US$6.65 million in Q1 2026, insider activity indicates more buying than selling over three months. Revenue is expected to grow by 24.6% per year, surpassing market averages. However, substantial insider selling and legal challenges pose risks amidst partnerships with credit unions expanding its lending platform's reach. Take a closer look at Upstart Holdings' potential here in our earnings growth report. Insights from our recent valuation report point to the potential overvaluation of Upstart Holdings shares in the market. Simply Wall St Growth Rating: ★★★★☆☆ Overview: StubHub Holdings, Inc. operates a global ticketing marketplace for live event tickets and has a market cap of $2.81 billion. Operations: The company generates revenue through its worldwide ticketing marketplace for live events. Insider Ownership: 13% Earnings Growth Forecast: 80.3% p.a. StubHub Holdings is forecast to achieve profitability within three years, with earnings expected to grow significantly at 80.31% annually. Recent Q1 results show a turnaround with US$48.05 million net income, compared to a loss last year. Revenue growth of 14.6% annually outpaces the US market average but remains below 20%. Strategic partnerships and AI integrations enhance its distribution capabilities, though insider trading activity lacks substantial recent buying or selling signals. Click to explore a detailed breakdown of our findings in StubHub Holdings' earnings growth report. Our valuation report here indicates StubHub Holdings may be undervalued. Gain an insight into the universe of 181 Fast Growing US Companies With High Insider Ownership by clicking here. Ready To Venture Into Other Investment Styles? Find companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.The analysis only considers stock directly held by insiders. It does not include indirectly owned stock through other vehicles such as corporate and/or trust entities. All forecast revenue and earnings growth rates quoted are in terms of annualised (per annum) growth rates over 1-3 years. Companies discussed in this article include EOLS UPST and STUB. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

After successful completion of FDA Type C meeting, Clene expects to submit an NDA for CNM-Au8® under the accelerated approval pathway in the third quarter of 2026 In January 2026, Clene completed an oversubscribed registered direct offering totaling over $28 million, including an initial tranche of more than $6 million and two additional tranches totaling over $22 million tied to regulatory milestones In May 2026, Clene amended its existing $10 million convertible debt facility, extending maturity by six months to August 2027 and eliminating required monthly principal and interest payments before maturity In May 2026, Clene completed a $7 million underwritten registered direct offering with a single investor SALT LAKE CITY, May 14, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late-stage clinical biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its first quarter 2026 financial results and provided recent updates on its CNM-Au8 programs. “We were encouraged by the constructive dialogue during our recent Type C meeting with the FDA and appreciate the Agency’s engagement as we advance toward a planned NDA submission for CNM-Au8 under the accelerated approval pathway for patients with ALS,” said Rob Etherington, President and CEO of Clene. “People living with ALS continue to need additional treatment options, and we believe CNM-Au8 has the potential to restore and protect neuronal health and function, leading to improved survival. We look forward to continuing to work collaboratively with the FDA as the Agency reviews our extensive clinical efficacy and safety data.” First Quarter 2026 and Recent Operating Highlights CNM-Au8 for the treatment of ALS Clene had a successful Type C in-person meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026 to discuss the statistically significant reductions in neurofilament light (NfL), including the relationship between the magnitude of NfL reduction and clinical benefits, including longer survival in participants treated with CNM-Au8. During the meeting, and as confirmed in the final meeting minutes, the FDA stated that the “proposed data may be capable of supporting the submission and review of an [NDA] under the accelerated approval pathway for the treatment of ALS.” The FDA also reminded the Company that the submission should demonstrate that CNM-Au8 has an effect on NfL and that the magnitude of change in NfL is reasonably likely to predict clinical benefits in patients with ALS. Clene intends to submit the New Drug Application (NDA) in the third quarter of 2026. Also, Clene plans to commence the confirmatory Phase 3 trial in the first quarter of 2027. The RESTORE-ALS trial is designed to investigate the effects of CNM-Au8 on improved survival (primary endpoint) and delayed time to ALS clinical worsening events (secondary efficacy endpoint). Corporate Update In January, Clene announced an oversubscribed registered direct offering of over $28.0 million priced above market. The initial tranche was over $6.0 million with two potential additional financing tranches totaling over $22.0 million structured around CNM-Au8 NDA acceptance and FDA approval milestones. In May, the Company closed an underwritten registered direct common stock offering to a single investor totaling $7.0 million in gross proceeds. Also in May, the Company amended its existing $10.0 million convertible debt facility to extend the maturity date to August 2027 and to eliminate any required principal and interest payments prior to maturity in August 2027. First Quarter 2026 Financial Results Clene’s cash and cash equivalents totaled $5.9 million as of March 31, 2026, compared to $5.2 million as of December 31, 2025. Clene expects that its resources as of March 31, 2026, including the $7.0 million in gross proceeds received from its May 2026 registered direct offering and the effects of its May 2026 amendment of its $10.0 convertible debt facility (requiring no principal or interest payments until August 2027), will provide operating runway into the fourth quarter of 2026. Additionally, with potential future warrant exercises tied to the acceptance of an NDA by the FDA of approximately $7.0 million, cash runway is expected to extend into 2027. Research and development expenses were $0.3 million for the quarter ended March 31, 2026, compared to $1.5 million for the same period in 2025. The year-over-year decrease was primarily due to decreased expenses related to our ALS program including two of our ongoing expanded access programs (EAPs) and planning activities for the RESTORE-ALS clinical trial, partially offset by an increase in expenses for regulatory activities primarily related to the ongoing FDA discussions and NDA submission-related activities and increased expenses for our MS program related to an ongoing EAP. Additionally, manufacturing related expenses, as well as expenses related to personnel and stock-based compensation, also decreased. General and administrative expenses were $1.7 million for the quarter ended March 31, 2026, compared to $2.7 million for the same period in 2025. The year-over-year decrease was primarily attributable to decreased personnel and stock-based compensation expenses, as well as lower legal fees and depreciation expense. Additionally, grant revenue, which is recorded as a reduction to general and administration expense, increased in 2026 as compared to 2025 primarily related to reimbursable general and administrative expenses in the National Institutes of Health (NIH) sponsored EAP. Total other expense, net, was $6.0 million for the quarter ended March 31, 2026, compared to total other income, net, of $3.3 million for the same period in 2025. The year-over-year change was primarily attributable to issuance costs for common stock warrant liabilities and a one-time loss on the initial issuance of equity related to our January 2026 financing, as well as fair value changes on existing warrant and derivative liabilities. In addition, during 2026 we had higher interest expense based on larger debt balances. Clene reported a net loss of $8.1 million, or $0.69 per share, for the quarter ended March 31, 2026, compared to a net loss of $0.8 million, or $0.09 per share, for the same period in 2025. About 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. CNM-Au8® 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® 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 www.clene.com or follow us on X (formerly Twitter) and LinkedIn. About CNM-Au8® CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. Forward-Looking Statements 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 and our cash runway. 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. 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. 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 materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; 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. 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. 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. Investor Contact: Kevin Gardner, LifeSci Advisors; [email protected]; 617-283-2856 CLENE INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Unaudited) CLENE INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) (Unaudited)

Over the last 7 days, the United States market has risen by 1.5%, contributing to a remarkable 26% climb over the past year, with earnings forecasted to grow by 17% annually. In this flourishing environment, growth companies with high insider ownership can be particularly appealing as they often indicate strong confidence from those closest to the business and potential for substantial earnings expansion. Click here to see the full list of 185 stocks from our Fast Growing US Companies With High Insider Ownership screener. Let's explore several standout options from the results in the screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing chimeric antigen receptor cell therapy for light chain amyloidosis and immune-mediated diseases, with a market cap of $525.88 million. Operations: Revenue Segments (in millions of $): null Insider Ownership: 12.8% Earnings Growth Forecast: 63.4% p.a. Immix Biopharma is a growth-focused company with high insider ownership, currently navigating financial challenges with a reported net loss of US$10.09 million for Q1 2026. Despite this, its revenue is forecasted to grow significantly faster than the US market at 56.6% annually, driven by promising developments like NXC-201 for AL Amyloidosis. The company anticipates profitability within three years, although it has experienced substantial shareholder dilution and share price volatility recently. Get an in-depth perspective on Immix Biopharma's performance by reading our analyst estimates report here. Our valuation report here indicates Immix Biopharma may be overvalued. Simply Wall St Growth Rating: ★★★★★☆ Overview: Rumble Inc. operates a video sharing and cloud services platform across the United States, Canada, and internationally, with a market cap of approximately $2.77 billion. Operations: The company's revenue is generated from its Internet Software & Services segment, amounting to $100.62 million. Insider Ownership: 35.9% Earnings Growth Forecast: 56.8% p.a. Rumble Inc. exhibits high insider ownership and is positioned for substantial growth, with revenue forecasted to expand at 42.5% annually, outpacing the US market. Recent initiatives like the OpenClaw Starter package on Rumble Cloud highlight its innovative approach in AI infrastructure. Despite a history of volatility and financial losses, Rumble's strategic leadership changes and product expansions aim to drive profitability within three years, reflecting its commitment to long-term value creation amidst market challenges. Click to explore a detailed breakdown of our findings in Rumble's earnings growth report. Upon reviewing our latest valuation report, Rumble's share price might be too optimistic. Simply Wall St Growth Rating: ★★★★★☆ Overview: Once Upon A Farm, PBC is a company that produces and sells organic baby food pouches, meals, and snacks for children with a market cap of $643.58 million. Operations: The company's revenue is derived from the production and sale of organic baby food pouches, meals, and snacks for children. Insider Ownership: 13.7% Earnings Growth Forecast: 55.8% p.a. Once Upon A Farm PBC demonstrates significant insider ownership and is poised for growth, with revenue projected to increase at 20.6% annually, surpassing US market averages. The company recently reported a substantial sales increase to US$72.72 million in Q1 2026 from US$50.6 million the previous year, while reducing net losses. Strategic product expansions and the formation of a Public Benefit Corporation Advisory Board underscore its commitment to sustainable growth and impactful business practices amidst evolving market demands. Unlock comprehensive insights into our analysis of Once Upon A Farm PBC stock in this growth report. Our expertly prepared valuation report Once Upon A Farm PBC implies its share price may be too high. Unlock our comprehensive list of 185 Fast Growing US Companies With High Insider Ownership by clicking here. Ready For A Different Approach? These 23 companies survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. Discover why before your portfolio feels the trade war pinch. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.The analysis only considers stock directly held by insiders. It does not include indirectly owned stock through other vehicles such as corporate and/or trust entities. All forecast revenue and earnings growth rates quoted are in terms of annualised (per annum) growth rates over 1-3 years. Companies discussed in this article include IMMX RUM and OFRM. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

The United States market has recently experienced a notable upswing, climbing 3.6% in the last week and showing a robust 39% increase over the past year, with earnings projected to grow by 16% annually in the coming years. In this favorable environment, growth companies with high insider ownership can be particularly appealing as they often demonstrate strong confidence from those who know the business best and have vested interests in its success. Click here to see the full list of 202 stocks from our Fast Growing US Companies With High Insider Ownership screener. Let's take a closer look at a couple of our picks from the screened companies. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Clearfield, Inc. designs, manufactures, and distributes fiber management, protection, and delivery products globally with a market cap of $415.12 million. Operations: The company's revenue segment is primarily derived from its fiber management, protection, and delivery products, totaling $154.78 million. Insider Ownership: 18.3% Earnings Growth Forecast: 61.1% p.a. Clearfield's insider ownership aligns with its growth prospects, as earnings are forecast to grow significantly at 61.1% annually, outpacing the US market. Despite recent losses, Clearfield became profitable this year and expects net sales between US$160 million and US$170 million for fiscal 2026. Substantial insider buying occurred over the past three months, reflecting confidence in future performance. Recent presentations at major industry events highlight ongoing efforts to strengthen market presence and investor relations. Unlock comprehensive insights into our analysis of Clearfield stock in this growth report. In light of our recent valuation report, it seems possible that Clearfield is trading beyond its estimated value. Simply Wall St Growth Rating: ★★★★★☆ Overview: Alphatec Holdings, Inc. is a medical technology company that focuses on designing and developing technologies for the surgical treatment of spinal disorders, with a market cap of approximately $1.68 billion. Operations: The company generates revenue primarily from its Medical Products segment, which accounted for $764.16 million. Insider Ownership: 10.4% Earnings Growth Forecast: 56.9% p.a. Alphatec Holdings' insider ownership supports its growth trajectory, with earnings projected to grow significantly at 56.89% annually and revenue expected to outpace the US market at 13.6% per year. Despite recent losses, the company is on track for profitability within three years. Analysts agree on a potential stock price increase of 110%. Recent board changes and participation in key industry conferences reflect strategic positioning, while trading remains below fair value estimates by 51.8%. Navigate through the intricacies of Alphatec Holdings with our comprehensive analyst estimates report here. In light of our recent valuation report, it seems possible that Alphatec Holdings is trading behind its estimated value. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Marcus & Millichap, Inc. is an investment brokerage company offering commercial real estate investment sales, financing services, and research and advisory services in the United States and Canada, with a market cap of approximately $1.06 billion. Operations: The company's revenue primarily comes from its commercial real estate services, amounting to $755.16 million. Insider Ownership: 38.7% Earnings Growth Forecast: 63.8% p.a. Marcus & Millichap's insider ownership aligns with its growth prospects, as earnings are expected to grow at 63.76% annually, surpassing the US market's average. Although revenue growth of 12.9% per year is below the 20% threshold, it still exceeds the broader market rate of 10.9%. Recent financials show improved net income and reduced losses year-over-year, while strategic share buybacks and conference participation indicate a proactive approach to enhancing shareholder value and industry engagement. Get an in-depth perspective on Marcus & Millichap's performance by reading our analyst estimates report here. Insights from our recent valuation report point to the potential overvaluation of Marcus & Millichap shares in the market. Click this link to deep-dive into the 202 companies within our Fast Growing US Companies With High Insider Ownership screener. Seeking Other Investments? The end of cancer? These 31 emerging AI stocks are developing tech that will allow early idenification of life changing disesaes like cancer and Alzheimer's. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.The analysis only considers stock directly held by insiders. It does not include indirectly owned stock through other vehicles such as corporate and/or trust entities. All forecast revenue and earnings growth rates quoted are in terms of annualised (per annum) growth rates over 1-3 years. Companies discussed in this article include CLFD ATEC and MMI. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

The United States market has experienced a notable upswing, climbing 4.4% in the last week and showing a robust 32% increase over the past year, with earnings forecasted to grow by 16% annually. In this thriving environment, identifying growth companies with high insider ownership can be particularly appealing as they often signal confidence from those closest to the business and potential alignment with shareholder interests. Click here to see the full list of 202 stocks from our Fast Growing US Companies With High Insider Ownership screener. We're going to check out a few of the best picks from our screener tool. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Loar Holdings Inc. designs, manufactures, and sells aerospace and defense components for aircraft and systems both in the United States and internationally, with a market cap of $6.19 billion. Operations: The company generates revenue of $496.28 million from its aerospace and defense segments, focusing on components for aircraft and related systems in both domestic and international markets. Insider Ownership: 17.6% Earnings Growth Forecast: 24.4% p.a. Loar Holdings exhibits strong growth potential with earnings forecasted to grow significantly at 24.4% annually, outpacing the US market. Recent results show a substantial increase in net income and sales for both the fourth quarter and full year 2025, reflecting robust performance. Insider confidence is evident as more shares were bought than sold recently. However, challenges persist with low future return on equity and debt not well covered by operating cash flow. Navigate through the intricacies of Loar Holdings with our comprehensive analyst estimates report here. The valuation report we've compiled suggests that Loar Holdings' current price could be inflated. Simply Wall St Growth Rating: ★★★★★☆ Overview: Paymentus Holdings, Inc. offers cloud-based bill payment technology and solutions both in the United States and internationally, with a market cap of approximately $3.22 billion. Operations: The company generates revenue from its cloud-based bill payment technology and solutions, with services to financial companies amounting to $1.20 billion. Insider Ownership: 30.6% Earnings Growth Forecast: 24.6% p.a. Paymentus Holdings demonstrates strong growth potential with earnings expected to rise significantly at 24.6% annually, exceeding the US market average. Recent financial results show a notable increase in both net income and sales for Q4 and full year 2025. Despite no substantial insider buying or selling recently, insider ownership remains high, indicating confidence in the company's future prospects. Revenue is forecasted to grow at 15.8% annually, surpassing the overall market growth rate. Click here and access our complete growth analysis report to understand the dynamics of Paymentus Holdings. Upon reviewing our latest valuation report, Paymentus Holdings' share price might be too optimistic. Simply Wall St Growth Rating: ★★★★★☆ Overview: Zeta Global Holdings Corp. operates an omnichannel data-driven cloud platform offering consumer intelligence and marketing automation software to enterprises globally, with a market cap of approximately $3.82 billion. Operations: The company generates revenue from its Internet Software & Services segment, amounting to $1.30 billion. Insider Ownership: 12.8% Earnings Growth Forecast: 43.8% p.a. Zeta Global Holdings is positioned for significant growth, with earnings forecasted to rise 43.84% annually and revenue expected to outpace the US market at 15.1% per year. The company trades at a substantial discount to its estimated fair value and is set to become profitable within three years, outperforming average market growth expectations. Recent product innovations like Athena by Zeta™ enhance operational efficiency, while raised revenue guidance for 2026 underscores strong future prospects despite past net losses. Get an in-depth perspective on Zeta Global Holdings' performance by reading our analyst estimates report here. According our valuation report, there's an indication that Zeta Global Holdings' share price might be on the cheaper side. Unlock more gems! Our Fast Growing US Companies With High Insider Ownership screener has unearthed 199 more companies for you to explore.Click here to unveil our expertly curated list of 202 Fast Growing US Companies With High Insider Ownership. Want To Explore Some Alternatives? Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.The analysis only considers stock directly held by insiders. It does not include indirectly owned stock through other vehicles such as corporate and/or trust entities. All forecast revenue and earnings growth rates quoted are in terms of annualised (per annum) growth rates over 1-3 years. Companies discussed in this article include LOAR PAY and ZETA. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

In the last week, the United States market has stayed flat, yet it has risen by 16% over the past year with expectations of a 15% annual earnings growth in the coming years. In this context, identifying growth companies with high insider ownership can be advantageous as they often align management interests with shareholder value and may capitalize on favorable market conditions. Click here to see the full list of 205 stocks from our Fast Growing US Companies With High Insider Ownership screener. Let's dive into some prime choices out of the screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Krystal Biotech, Inc. is a commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing genetic medicines for diseases with high unmet medical needs in the United States, with a market cap of $7.22 billion. Operations: The company's revenue is primarily derived from its genetic medicines aimed at addressing diseases with high unmet medical needs, totaling $389.13 million. Insider Ownership: 10% Earnings Growth Forecast: 28.9% p.a. Krystal Biotech demonstrates strong growth potential, with earnings forecasted to grow significantly at 28.9% annually, outpacing the US market. Recent earnings results showed substantial improvement, with full-year net income reaching US$204.83 million compared to US$89.16 million the previous year. The FDA's RMAT designation for KB707 highlights promising developments in their pipeline, particularly for advanced non-small cell lung cancer treatment. Despite trading below fair value estimates and analyst price targets, insider trading activity remains stable over recent months. Click to explore a detailed breakdown of our findings in Krystal Biotech's earnings growth report. Our valuation report here indicates Krystal Biotech may be undervalued. Simply Wall St Growth Rating: ★★★★★☆ Overview: Klaviyo, Inc. offers a cloud-based software-as-a-service platform across various regions including the Americas, Asia-Pacific, Europe, the Middle East, and Africa with a market cap of $5.78 billion. Operations: The company's revenue primarily comes from its Internet Software segment, which generated $1.23 billion. Insider Ownership: 36.6% Earnings Growth Forecast: 81.7% p.a. Klaviyo is positioned for growth with its expanding product capabilities, such as Composer and enhanced Shopify integration, driving revenue forecasted to grow 16.2% annually, surpassing the US market average. The company recently announced a $500 million share buyback program and maintains strong insider ownership with more shares bought than sold in recent months. Despite trading at 26.5% below fair value estimates, Klaviyo's expected profitability within three years signals robust potential for investors focused on high-growth opportunities. Delve into the full analysis future growth report here for a deeper understanding of Klaviyo. In light of our recent valuation report, it seems possible that Klaviyo is trading behind its estimated value. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Sea Limited operates as a consumer internet company through its subsidiaries, serving markets in Southeast Asia, Latin America, the rest of Asia, and internationally with a market cap of approximately $46.36 billion. Operations: The company's revenue is primarily derived from its Shopee segment at $16.56 billion, followed by Monee at $3.79 billion and Garena at $2.41 billion. Insider Ownership: 14.7% Earnings Growth Forecast: 21.7% p.a. Sea Limited's earnings grew 255.2% last year, with revenue expected to increase 16.2% annually, outpacing the US market average of 10.3%. Forecasted earnings growth at 21.7% per year also exceeds the market's rate of 15.4%. Despite trading at a significant discount to its estimated fair value, insider ownership remains strong, though recent share buybacks were modest at $14.5 million for 116,200 shares completed by December 2025. Get an in-depth perspective on Sea's performance by reading our analyst estimates report here. Our valuation report unveils the possibility Sea's shares may be trading at a discount. Delve into our full catalog of 205 Fast Growing US Companies With High Insider Ownership here. Contemplating Other Strategies? AI is about to change healthcare. These 122 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10b in market cap - there's still time to get in early. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.The analysis only considers stock directly held by insiders. It does not include indirectly owned stock through other vehicles such as corporate and/or trust entities. All forecast revenue and earnings growth rates quoted are in terms of annualised (per annum) growth rates over 1-3 years. Companies discussed in this article include KRYS KVYO and SE. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Over the last 7 days, the United States market has experienced a 3.5% drop, yet it has risen by 14% over the past year with earnings projected to grow by 15% annually in the coming years. In this environment, growth companies with high insider ownership can be particularly appealing as they may align management's interests with shareholders and potentially drive significant earnings growth. Click here to see the full list of 205 stocks from our Fast Growing US Companies With High Insider Ownership screener. We'll examine a selection from our screener results. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Merchants Bancorp is a diversified bank holding company operating in the United States, with a market cap of approximately $1.94 billion. Operations: The company generates revenue through its Banking segment with $240.62 million, Mortgage Warehousing at $149.20 million, and Multi-Family Mortgage Banking contributing $173.81 million. Insider Ownership: 36.1% Earnings Growth Forecast: 20.2% p.a. Merchants Bancorp, with strong insider ownership, is positioned for growth with earnings projected to rise significantly at 20.2% annually, outpacing the US market. Despite a recent dip in net income and earnings per share, it trades below its estimated fair value and offers good relative value compared to peers. Recent inclusion in major indices like the S&P 1000 highlights its growing prominence. The company also announced a $100 million share buyback program valid through 2027. Click to explore a detailed breakdown of our findings in Merchants Bancorp's earnings growth report. Our comprehensive valuation report raises the possibility that Merchants Bancorp is priced lower than what may be justified by its financials. Simply Wall St Growth Rating: ★★★★★★ Overview: Better Home & Finance Holding Company operates as a homeownership company in the United States with a market cap of approximately $504.35 million. Operations: The company's revenue primarily comes from its Home Finance segment, generating $157.26 million, and its Banking segment, contributing $7.61 million. Insider Ownership: 19.9% Earnings Growth Forecast: 97.4% p.a. Better Home & Finance Holding, with significant insider ownership, is poised for growth as it leverages innovative strategies like token-backed mortgages in partnership with Coinbase. The company is forecast to achieve high revenue growth of 32.7% annually and expects to become profitable within three years. Despite recent losses, Better's integration of AI technology through its Tinman platform and strategic board appointments aim to enhance operational efficiency and guide its long-term expansion in the mortgage industry. Click here to discover the nuances of Better Home & Finance Holding with our detailed analytical future growth report. Our valuation report unveils the possibility Better Home & Finance Holding's shares may be trading at a premium. Simply Wall St Growth Rating: ★★★★★☆ Overview: Cardinal Infrastructure Group Inc. is a civil contracting company offering site development and infrastructure services across various sectors in the southeastern United States, with a market cap of $569.66 million. Operations: The company's revenue is primarily generated from its heavy construction segment, which accounts for $456.05 million. Insider Ownership: 10.6% Earnings Growth Forecast: 79.7% p.a. Cardinal Infrastructure Group, with substantial insider ownership, demonstrates strong growth potential as it expands its operations and strengthens management. The company reported US$456.05 million in sales for 2025, a significant increase from the previous year, though profit margins declined to 0.2%. Recent executive appointments and inclusion in multiple Russell indices highlight its strategic positioning. Cardinal's earnings are forecast to grow significantly at 79.7% annually, outpacing the market's growth expectations. Take a closer look at Cardinal Infrastructure Group's potential here in our earnings growth report. Our expertly prepared valuation report Cardinal Infrastructure Group implies its share price may be too high. Click through to start exploring the rest of the 202 Fast Growing US Companies With High Insider Ownership now. Looking For Alternative Opportunities? The latest GPUs need a type of rare earth metal called Neodymium and there are only 25 companies in the world exploring or producing it. Find the list for free. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.The analysis only considers stock directly held by insiders. It does not include indirectly owned stock through other vehicles such as corporate and/or trust entities. All forecast revenue and earnings growth rates quoted are in terms of annualised (per annum) growth rates over 1-3 years. Companies discussed in this article include MBIN BETR and CDNL. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the latest CNM-Au8® data submitted; Clene expects formal written meeting minutes early in the second quarter 2026 Oversubscribed registered direct offering of over $28 million priced above market Initial financing tranche of over $6 million, which will provide cash runway to the end of the third quarter enabling funding through potential NDA acceptance decision by the FDA Completion of this financing through its three tranches is expected to provide the Company with sufficient capital into 2027 SALT LAKE CITY, March 12, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its full year 2025 financial results and provided recent updates on its CNM-Au8 programs. “Our next key milestone is the upcoming Type C face-to-face meeting with the U.S. Food and Drug Administration (FDA) on Clene’s biomarker and survival data, which if positive, will facilitate filing of an new drug application (NDA) under an accelerated approval pathway for ALS by the end of the second quarter of 2026,” said Rob Etherington, President and CEO of Clene. “In parallel, we continue to advance plans to initiate our confirmatory Phase 3 trial in ALS, which is required to be “underway” by CNM-Au8 approval in ALS, as well as to continue working with the FDA on the initiation of a Phase 3 clinical trial using cognition as an endpoint in MS. Based on our combined findings to date, we continue to believe that patients across multiple neurodegenerative conditions may benefit from the improved mitochondrial function plus energy metabolism associated with CNM-Au8 treatment.” Fourth Quarter 2025 and Recent Operating Highlights CNM-Au8 for the treatment of ALS Clene expects its Type-C meeting with the FDA will occur before the end of this month. Clene will then await formal written meeting minutes from the agency which are expected early in the second quarter of 2026, after which Clene will publicly announce the outcome of the FDA meeting. Clene plans to file an NDA for CNM-Au8 in ALS under an accelerated approval pathway by the end of June 2026. Prolonged Survival and Associated Declines in Biomarkers of Neurodegeneration In December 2025, the Company announced completion of the FDA-recommended biomarker analyses for CNM-Au8 in people living with ALS. The results demonstrated statistically significant reductions in both neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) and provided compelling evidence linking biomarker decline to improved survival. The analyses followed FDA recommendations to support the persuasiveness of the Company’s original NfL findings observed in the HEALEY ALS Platform Trial by extending the analyses to the NIH-sponsored Expanded Access Protocol (NIH-EAP) for CNM-Au8 in ALS. These biomarker findings correlated to survival findings and build on prior constructive FDA interactions in support of a planned NDA submission under an accelerated approval pathway for the treatment of ALS. Favorable Safety and Benefit/Risk Profile Across over 1,100 patient years of CNM-Au8 exposure data, with long-term treatment of people with ALS over 6 years, CNM-Au8’s safety profile has no significant safety concerns nor safety trends identified. No serious adverse events (SAEs) have been identified as related to CNM-Au8 treatment by any investigator to date. Corporate Update In January, Clene announced an oversubscribed registered direct offering of over $28 million priced above market. The initial tranche of over $6 million is expected to provide operating runway to the end of the third quarter of 2026, sufficient funding through a potential NDA acceptance decision by the FDA. Two potential additional financing tranches totaling over $22 million are structured to align with NDA acceptance and FDA approval milestones and provide runway into 2027. Full Year 2025 Financial Results Clene’s cash and cash equivalents totaled $5.2 million as of December 31, 2025, compared to $12.2 million as of December 31, 2024. Clene expects that its resources as of December 31, 2025, combined with the proceeds received from its January 2026 registered direct offering, will provide operating runway to the end of the third quarter of 2026 with potential additional tranches of financing from this offering extending its cash runway into 2027. Research and development expenses were $14.0 million for the year ended December 31, 2025, compared to $20.1 million for the same period in 2024. The year-over-year decrease was primarily due to decreased expenses related to the HEALEY ALS Platform Trial and RESCUE-ALS due to their previous completion of the blinded portion and open-label extensions of each trial, a decrease in expenses for regulatory activities, and a decrease in pre-clinical, non-clinical and other general CNM-Au8 related expenses, partially offset by an increase in expenses related to the NIH-EAP due to higher enrollment in the EAP. Manufacturing related expenses, as well as expenses related to personnel and stock-based compensation, also decreased. Additionally, grant revenue, which is recorded as a reduction to research and development expense, significantly increased in 2025 as compared to 2024 primarily related to an increase in enrollment and study operations of the NIH-EAP. General and administrative expenses were $9.2 million for the year ended December 31, 2025, compared to $13.3 million for the same period in 2024. The year-over-year decrease was primarily attributable to lower insurance fees, legal fees and public and investor relations fees, as well as decreased personnel and stock-based compensation expenses, partially offset by an increase in finance and accounting fees. Additionally, grant revenue, which is recorded as a reduction to general and administration expense, increased in 2025 as compared to 2024 primarily related to an increase in enrollment and study operations of the NIH- EAP. Total other expense, net, was $3.1 million for the year ended December 31, 2025, compared to $6.3 million for the same period in 2024. The year-over-year decrease in other expense was primarily attributable to lower interest expense and smaller changes in warrant and derivative liabilities. Additionally, a one-time loss on extinguishment of notes payable and a loss on initial issuance of equity only occurred in 2024. Clene reported a net loss of $26.2 million, or $2.65 per share, for the year ended December 31, 2025, compared to a net loss of $39.4 million, or $5.67 per share, for the same period in 2024. About 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. CNM-Au8® 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® 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 www.clene.com or follow us on X (formerly Twitter) and LinkedIn. About CNM-Au8® CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. Forward-Looking Statements 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 meeting with the FDA, the Company’s operating cash runway, the potential for additional tranches of financing and the timing of such financings, the timing of the Company’s NDA submission, and that the biomarker findings support an NDA submission. 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. 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. 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 materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; 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. 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. 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. Investor Contact: Kevin Gardner, LifeSci Advisors; [email protected]; 617-283-2856 CLENE INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Audited) CLENE INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) (Audited)

FDA recommended biomarker analyses show statistically significant reductions in NfL and GFAP in participants treated with CNM-Au8 Biomarker improvements are strongly associated with longer survival, reinforcing CNM-Au8’s potential disease modifying activity Company has requested a Type C meeting in the first quarter of 2026 to present the newly completed analyses supporting a planned NDA submission under the accelerated approval pathway Clene is hosting an investor webcast today at 8:30 am ET SALT LAKE CITY, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced completion of the FDA-recommended biomarker analyses for CNM-Au8® in people living with ALS. The results demonstrate statistically significant reductions in both neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) and provide compelling evidence linking biomarker decline to improved survival. “We followed the FDA’s roadmap — and the data delivered,” said Rob Etherington, President and CEO of Clene. “Statistically significant NfL reductions in more advanced real-world ALS patients; a second independent disease-specific biomarker (GFAP) that moves in lock-step with NfL and is itself statistically significant; and clear evidence in placebo switchers (placebo-to-CNM-Au8) showing that CNM-Au8-treated participant’s biomarkers follow nearly identical trajectories seen in the original active arm during the double-blind treatment phase of the HEALEY ALS Platform Trial. This is a remarkably consistent dataset that makes a strong case for accelerated approval. We look forward to presenting these analyses to the Division in the requested Type C meeting in the first quarter of 2026 and working with the FDA toward an NDA submission for accelerated approval.” The analyses follow FDA recommendations to support the persuasiveness of the original NfL findings observed in the HEALEY ALS Platform Trial by extending the analyses to the NIH-sponsored EAP (NIH-EAP) for CNM-Au8 in ALS. These biomarker findings build on prior constructive FDA interactions in support of a planned NDA submission under the accelerated approval pathway for the treatment of ALS. New Biomarker Analyses In late 2024, the FDA recommended three specific analyses to strengthen the persuasiveness of CNM-Au8’s effect on NfL and its relationship to clinical benefit (i.e., effects on survival): (1) NfL change in the NIH-EAP, (2) evaluation of additional disease-relevant biomarkers, and (3) evaluation of NfL trajectory in HEALEY placebo participants who later transitioned to CNM-Au8 in the open-label extension (OLE): CNM-Au8 Strengthens Overall Survival Signal in the HEALEY ALS Platform Trial Open-Label Extension Period Updated survival analyses (April 2025 data cut) in participants originally randomized to CNM-Au8 30 mg in the HEALEY ALS Platform Trial continue to demonstrate clinically meaningful and statistically significant survival benefit versus concurrent Regimen A controls. Analyses were conducted at intervals of one year (pre-specified OLE timepoint) and beyond using the pre-specified HEALEY ALS Platform Trial covariate model across two populations: the full analysis set (FAS), including all available participant data; and a risk-balanced population, the comparable risk set (CRS) (filtered for disease severity by NfL levels (Ln(NfL) > 3.5 and TRICALS risk score)) due to imbalances with significantly more low-progression risk patients present in the Regimen A group. CNM-Au8 30 mg treatment demonstrated statistically significant improved survival across both the FAS and CRS populations based on a Cox proportional hazard model and restricted mean survival time (RMST) analyses. In the FAS population: 1-year Cox proportional hazard ratio: 0.2723, 95% CI: 0.0961 – 0.7719, p=0.0144 → 73% reduction in risk of death In the CRS population: 1-year Cox proportional hazard ratio: 0.229, 95% CI: 0.07 – 0.752, p = 0.0151 → 77% reduction in risk of death Even the small cohort of placebo-to-CNM-Au8 switchers (n=31, starting treatment ~6 months later in disease progression) showed a significant RMST benefit of +30.7 days at one year following treatment initiation (95% CI 7.52 – 53.85, p=0.0094). Strong CNM-Au8 Safety Profile Across over 1,000 patient years of CNM-Au8 exposure data, treatment with CNM-Au8 continues to demonstrate a safety profile without significant safety concerns or safety trends identified. No serious adverse events (SAEs) have been identified as related to CNM-Au8 treatment by any investigator to date. ALS Key Opinion Leader Commentary “We believe these data show the potential enduring effect of CNM-Au8, because this NIH-EAP data includes participants who are generally more advanced than a typical ALS clinical trial population and still show concordant NfL decline,” said Dr. Jinsy Andrews, MD, MSc, Director of the Amyotrophic Lateral Sclerosis Center and Medical Director of Clinical Trials in the Department of Neurology at NYU Grossman School of Medicine and principal investigator of the NIH-sponsored EAP. “The consistency of NfL and GFAP reductions in more advanced patients treated in the Expanded Access Program is particularly compelling and suggests potential disease-modifying activity of CNM-Au8.” Clene Submitted a Type C Meeting Request to Align on Accelerated Approval NDA Submission Clene has requested a Type C meeting with the FDA and anticipates the meeting will occur during the first quarter of 2026 to present the full dataset. The Company plans to submit an NDA under the accelerated approval pathway in the same quarter, with the planned Phase 3 RESTORE-ALS trial serving as the post-approval confirmatory study. The Company will host a conference call and webcast at 8:30 am ET today, on Wednesday, December 3, 2025, to provide an update on its CNM-Au8 program in ALS. Those who would like to participate may access the live webcast here: Webcast Information: Title: CNM-Au8 ALS Program Update Presenters: Rob Etherington, CEO and President; Dr. Ben Greenberg, Head of Medical; Michael Hotchkin, Chief Development Officer, and a KOL Date: Wednesday, December 3, 2025 Start Time: 8:30 a.m. EST Webcast link: https://viavid.webcasts.com/starthere.jsp?ei=1744985&tp_key=9fb9583d33 Dial number: 1-877-407-0779 (US) or 1-201-389-0914 (international), Conference ID#13757380 About 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. CNM-Au8® 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® 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 www.clene.com or follow us on X (formerly Twitter) and LinkedIn. About the NIH-Sponsored Expanded Access Program (NIH-EAP) for CNM-Au8 in ALS: This EAP is a collaborative effort between Clene Nanomedicine, NYU, and Synapticure, with a grant awarded by the NIH (NCT06408727). The program enrolled 183 participants at eight sites across the United States. Comparisons of NIH-EAP participants to natural history ALS controls were made using the U.S. ANSWER ALS dataset. A previously considered large European natural-history dataset was determined, upon detailed quality review, not to meet FDA-required quality standards. Clene therefore selected the U.S. ANSWER ALS dataset to ensure the most reliable and defensible external comparator for regulatory purposes. About CNM-Au8® CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. Forward-Looking Statements 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 meeting with the FDA, the timing of the Company’s NDA submission, and that the biomarker findings support an NDA submission. 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. 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. 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 materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; 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. 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. 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. Investor Contact: Kevin Gardner, LifeSci Advisors; [email protected]; 617-283-2856

As the U.S. Food and Drug Administration (FDA) proposed, Clene is concluding analyses of its ALS biomarker data with completion planned shortly The FDA advised Clene to request a Type C meeting to review these further ALS biomarker data analyses The Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathway The Company expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026 The FDA and Clene participated in a Type B end of Phase 2 meeting in the third quarter of 2025 to discuss the Company’s MS clinical development program and ongoing plans for MS development of CNM-Au8 Cash and cash equivalents of $7.9 million as of September 30, 2025 Cash runway extended into the second quarter of 2026, including $1.2 million additionally raised following the third quarter close SALT LAKE CITY, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its third quarter 2025 financial results and provided recent updates on its CNM-Au8 programs. “The three potential biomarker paths that could be leveraged to increase the persuasiveness of our ALS data, as outlined by the FDA, include: a) the NfL analysis of our ongoing NIH-sponsored Expanded Access Program (EAP); b) additional ALS disease-specific biomarker changes (in addition to NfL) from the HEALEY ALS Platform Trial; and c) NfL analysis of subjects in the open-label extension (OLE) of the HEALEY ALS Platform Trial who were initially treated with placebo during the placebo-controlled portion of the trial and then received CNM-Au8 during the OLE,” said Rob Etherington, President and CEO of Clene. “The Company anticipates completing these data analyses shortly which could support the filing of an NDA using the accelerated approval pathway.” Third Quarter 2025 and Recent Operating Highlights CNM-Au8 for the treatment of ALS Clene held a second Type C meeting with the FDA to review the long-term survival benefit from CNM-Au8 30 mg treatment compared to concurrently randomized controls from another HEALEY ALS Platform Trial regimen in the third quarter. Consistent with prior interactions, the FDA remains focused on demonstrated improvements in ALS disease-specific biomarkers to support a regulatory filing under the accelerated approval path, with analyses of overall survival potentially serving as confirmatory evidence. The FDA recommended three potential paths that could be leveraged to increase the persuasiveness of the Company’s data, including analyses of other ALS disease-specific biomarkers and the effect of CNM-Au8 on NfL decline in various studies (NIH-sponsored EAP and HEALEY ALS Platform trial). Further, as recommended by the FDA, Clene plans to request a Type C meeting with the FDA to review its data from these analyses, which meeting is expected to occur in the first quarter of 2026. Assuming the further ALS data analyses are consistent with previous results and incorporating FDA feedback, the Company plans to submit an NDA under an accelerated approval pathway. Clene also anticipates having the first patient dosed in its confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026. CNM-Au8 for the treatment of MS In September 2025, the Company held a Type B end-of-Phase 2 meeting with the FDA, during which Clene and the FDA reviewed results from the Phase 2 VISIONARY-MS trial and explored proposed endpoints for the planned Phase 3 study focusing on cognition improvement as an adjunct to standard-of-care MS therapies. The FDA aligned with Clene acknowledging the limitations of the Expanded Disability Status Scale and expressed openness to considering other potential primary endpoints, including cognition, to evaluate broader treatment effects. In September 2025, Clene presented the combined Phase 2 REPAIR-MS trial results across relapsing MS and non-active progressive MS during the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). CNM-Au8 improved the brain’s energy metabolism as evidenced by improvements to the NAD+/NADH ratio. CNM-Au8 for the treatment of PD In September 2025, Clene announced new preclinical data showing that CNM-Au8 improved key measures of cellular health in a novel dopaminergic neuron model of Parkinson’s disease (PD). This novel model for PD demonstrated CNM-Au8’s ability to improve mitochondrial health, restore cellular metabolism, reduce inflammation, and normalize dysregulated gene expression in both familial and sporadic PD. These new data support the continued development of CNM-Au8 as a treatment for PD. Third Quarter 2025 Financial Results Clene’s cash and cash equivalents totaled $7.9 million as of September 30, 2025, compared to $12.2 million as of December 31, 2024. Clene expects that its cash and cash equivalents as of September 30, 2025, together with $1.2 million raised subsequent to September 30, 2025, will be sufficient to fund its operations into the second quarter of 2026. Research and development expenses were $3.5 million for the quarter ended September 30, 2025, compared to $4.5 million for the same period in 2024. The year-over-year decrease was primarily related to decreased personnel expenses, primarily due to cost-saving initiatives, and a reduction in manufacturing expenses due to the conclusion of various clinical programs; a decrease in stock-based compensation expenses due to the timing of award grants, vesting and forfeitures; a decrease in expenses related to MS clinical programs; a decrease in expenses for regulatory activities related to ongoing FDA discussions and NDA submission-related activities; and an increase in grant revenue, recorded as a reduction in research and development expense, due to an increase in the enrollment and study operations in the NIH-sponsored EAP; partially offset by an increase in expenses related to the Company’s ongoing EAPs and planning activities for the Phase 3 RESTORE-ALS clinical trial. General and administrative expenses were $2.2 million for the quarter ended September 30, 2025, compared to $3.4 million for the same period in 2024. The year-over-year decrease was primarily related to decreases in legal fees, public and investor relations expenses, personnel expenses, and stock-based compensation expenses. Total other expense was $3.1 million for the quarter ended September 30, 2025, compared to total other expense of $0.2 million for the same period in 2024. The increase in other expense was primarily related to losses from the changes in fair value of common stock warrant liabilities and derivative liabilities, partially offset by decreases in interest expense. Clene reported a net loss of $8.8 million, or $0.85 per share, for the quarter ended September 30, 2025, compared to a net loss of $8.0 million, or $1.22 per share, for the same period in 2024. About 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. CNM-Au8® 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® 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 www.clene.com or follow us on X (formerly Twitter) and LinkedIn. About CNM-Au8® CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. Forward-Looking Statements 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 our analyses of potential biomarker paths, our plans to submit an NDA and the related timing, our expectations regarding the timing of the first patient dosing in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8, the timing of our data collection and analyses, and our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future operations. 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. 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. 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 materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; 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. 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. 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. Investor Contact: Kevin Gardner, LifeSci Advisors; [email protected]; 617-283-2856 CLENE INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Unaudited) CLENE INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) (Unaudited)