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1. Vertex Pharmaceuticals, but focused on finding a foundational treatment to restore brain cell energy and health across a range of neurodegenerative diseases like ALS and MS.

2. A biotech aiming to be like Biogen or Eli Lilly, but with a unique focus on restoring fundamental cellular energy for neurodegenerative conditions.

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• CNM-Au8: An investigational oral suspension of catalytically-active gold nanocrystals designed to improve cellular energy production and maintain neuronal health, with ongoing clinical trials for neurodegenerative diseases such as ALS and MS.

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Clene (CLNN) is a biotechnology company focused on the development of novel nanotherapeutics for neurodegenerative diseases. As the company's product candidates, such as CNM-Au8, are currently in various stages of clinical development and have not yet received regulatory approval for commercial sale, Clene does not have traditional "major customers" in the sense of selling products or services to other companies or individuals.

Clene's revenue to date has primarily consisted of grant funding for its research and development activities. Therefore, the primary entities contributing to Clene's revenue are government agencies that provide these grants. These are not publicly traded companies and thus do not have stock symbols.

The major entities providing grant revenue to Clene include:

• National Institute of Neurological Disorders and Stroke (NINDS) - A part of the National Institutes of Health (NIH), a U.S. government agency.
• Biomedical Advanced Research and Development Authority (BARDA) - A part of the U.S. Department of Health and Human Services (HHS), a U.S. government agency.

These organizations fund specific research and development projects undertaken by Clene.

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Rob Etherington, President & Chief Executive Officer

Mr. Etherington brings nearly 30 years of sales, marketing, and leadership experience in the pharmaceutical industry to Clene. He was appointed CEO in April 2013. Prior to joining Clene, he worked for Actelion Pharmaceuticals, which was acquired by Johnson & Johnson Pharmaceuticals in 2017. He joined Actelion as a founding Director of Marketing in 2000 and held various roles of increasing responsibility, leading U.S. commercial operations and being responsible for five marketed drugs. He also started his pharmaceutical career at Parke-Davis, a division of Pfizer, where he oversaw the drug Lipitor. As the founding CEO of Clene, Mr. Etherington has raised more than $150M in equity financings and has focused the company on neurodegenerative diseases.

Morgan Brown, Chief Financial Officer

Mr. Brown has over 29 years of finance and accounting experience, with 22 years dedicated to biotechnology, pharmaceutical, medical device, and clinical research companies. Before joining Clene as CFO, he served in similar capacities at Lipocine Inc. (NASDAQ: LPCN), Innovus Pharmaceuticals, Inc. (OTCBB: INNV), World Heart Corporation (NASDAQ: WHRT), Lifetree Clinical Research, and NPS Pharmaceuticals Inc. (NASDAQ: NPSP). Previously, he was a Senior Audit Manager at KPMG LLP. Mr. Brown has led efforts in evaluating, negotiating, and closing equity and debt financings totaling over $1 billion and out-licensing commercial-stage asset transactions totaling $220 million. He also has experience in M&A activities. Mr. Brown is a licensed certified public accountant in Utah.

Mark Mortenson, Chief Science Officer

Mr. Mortenson is the co-inventor of Clene's Clean-Surface Nanocrystal (CSN™) therapeutics technology platform and holds/co-holds 30 other U.S. patents and hundreds of foreign patents. Before Clene, he was the Chief Operating Officer of Research, Development, and Manufacturing for an advanced materials-based company with over 300 employees. He also served as a chief patent counsel, responsible for approximately 5,500 patents and patent applications. Mr. Mortenson is also a co-founder and Chief Technology Officer for Clene Nanomedicine.

Dr. Benjamin Greenberg, Head of Medical

Dr. Greenberg is an internationally recognized expert in central nervous system disorders. He also maintains his role as professor of neurology and Vice Chair of Clinical and Translational Research in the Department of Neurology at UT Southwestern Medical Center in Dallas, TX. His expertise covers the diagnosis and treatment of multiple sclerosis and other rare neurological disorders. Dr. Greenberg previously held faculty positions at Johns Hopkins and was recruited to UT Southwestern to direct new programs in transverse myelitis and neuromyelitis optica, and he founded the pediatric demyelinating disease program at Children's Medical Center.

Michael Hotchkin, Chief Development Officer

Mr. Hotchkin brings over 20 years of experience in pharmaceutical commercialization, planning, strategy development, and medical affairs to Clene. He leads commercial planning, strategy development, preclinical translational medicine, and regulatory filings for the company. He was a founding team member at Actelion Pharmaceuticals US, Inc., where he helped launch multiple products for orphan disorders and led commercialization efforts for the Genetic Business Unit, doubling sales for two pharmaceutical drugs. His contributions at Actelion included implementing global market planning activities, directing U.S. strategy, and leading marketing for several medicines. Mr. Hotchkin began his career at Parke-Davis, a subsidiary of Pfizer.

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Key Risks to Clene (CLNN)

1. Significant Financial Distress and Going Concern Risk: Clene has consistently reported substantial net losses, negative operating and net margins, and high debt levels, indicating poor financial strength. The company's precarious cash position and a Z-Score suggesting a high risk of bankruptcy within two years highlight significant challenges to its ability to continue as a going concern.
2. High Uncertainty in Clinical Development and Regulatory Approval: As a clinical-stage pharmaceutical company, Clene's business model is entirely reliant on the successful clinical development and regulatory approval of its drug candidates. Its lead candidate, CNM-Au8, has shown mixed results in past Phase 2 trials for ALS, and there is inherent uncertainty regarding the efficacy, safety, and commercial viability of its drug candidates, which could fail to materialize or face significant delays.
3. Market Volatility and Funding Challenges: Clene's stock exhibits higher volatility compared to the overall market. The company also faces ongoing difficulties in securing adequate funding to sustain its operations and advance its pipeline through development and commercialization. This is further evidenced by past non-compliance notices from Nasdaq related to minimum bid price requirements, reflecting instability in its market position and investor confidence.

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Clene Inc. (CLNN) is a clinical-stage biopharmaceutical company primarily focused on developing novel clean-surfaced nanotechnology (CSN) therapeutics, with its lead drug candidate being CNM-Au8. This investigational therapy is being studied for its potential in treating several neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson's Disease (PD). The addressable markets for these conditions are as follows:

• Amyotrophic Lateral Sclerosis (ALS): The global amyotrophic lateral sclerosis therapeutics market size is projected to grow from approximately $0.77 billion in 2024 to $1.80 billion by 2032. Another estimate places the global market at approximately $1.28 billion by the end of 2029. The U.S. market for ALS therapeutics was estimated at approximately $920 million in 2023.
• Multiple Sclerosis (MS): The global multiple sclerosis therapeutic market size was estimated at $27.39 billion in 2024 and is projected to reach $38.62 billion by 2030. Another source indicates the global market size is worth more than $23 billion annually. The market size for Multiple Sclerosis in the 7 Major Markets (7MM), which includes the U.S., France, Germany, Italy, Spain, the U.K., and Japan, is expected to grow from $20 billion in 2024.
• Parkinson's Disease (PD): The global Parkinson's disease drugs market size was valued at $7.17 billion in 2024 and is projected to grow to $13.46 billion by the end of 2032. Another estimate indicates the global Parkinson's disease therapeutics market was valued at $6.2 billion in 2024 and is set to reach $13.3 billion by 2034. The U.S. Parkinson's disease therapeutics market size was evaluated at $2.15 billion in 2024 and is predicted to be worth around $4.25 billion by 2034.

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Here are 3-5 expected drivers of future revenue growth for Clene (CLNN) over the next 2-3 years:

1. Potential New Drug Application (NDA) Submission and Accelerated Approval of CNM-Au8 for Amyotrophic Lateral Sclerosis (ALS): Clene is actively preparing for a potential NDA submission via the Accelerated Approval pathway for its lead drug candidate, CNM-Au8, in ALS by the fourth quarter of 2025. The company is engaged in discussions with the FDA regarding this pathway, including gathering and analyzing NfL biomarker data from its NIH-sponsored Expanded Access Program (EAP) in ALS patients. Successful approval would mark a significant transition to commercialization for this indication.
2. Commercialization and Sales Growth of CNM-Au8 in ALS: Following a potential accelerated approval for CNM-Au8 in ALS, the subsequent launch and market penetration of the drug would be a primary driver of revenue. Analysts forecast substantial annual revenue growth for Clene in the coming years, indicating expectations of product sales contributing meaningfully to the top line.
3. Advancement and Potential Commercialization of CNM-Au8 for Multiple Sclerosis (MS): Clene is also developing CNM-Au8 for the treatment of multiple sclerosis. Key FDA meetings regarding MS trial design are anticipated, which could determine the path to potential accelerated approval and attract partnerships. Successful clinical development and eventual market entry for CNM-Au8 in MS would unlock an additional significant revenue stream.

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Share Issuance

• Clene Inc. resolved an outstanding $125,000 debt through the issuance of 35,311 shares of common stock at $3.54 per share, as disclosed in an SEC filing on March 27, 2025.
• On September 30, 2024, Clene Inc. announced a registered direct offering and concurrent private placements, expecting to raise approximately $7.3 million in gross proceeds. This involved issuing 742,626 shares (or pre-funded warrants) to a healthcare-focused institutional investor at $4.713 per share, 681,469 shares (or pre-funded warrants) to existing stockholders at $4.713 per share, and 122,819 shares to directors and officers at $4.875 per share, with all offerings including warrants.
• In April 2024, Clene sought approval to amend its Certificate of Incorporation to increase the number of authorized shares of Common Stock to 600,000,000 and to increase the shares reserved for issuance under its Amended 2020 Stock Plan by 30,000,000 shares.

Capital Expenditures

• In the last 12 months (as of November 7, 2025), Clene had capital expenditures of -$2,000, resulting in a free cash flow of -$17.65 million.
• The company's capital assets, including laboratory equipment, furniture and fixtures, and computer software, are depreciated over estimated useful lives of 2-7 years.