Better Health for All

Clene Inc.'s core business is entirely devoted to developing novel therapeutics for neurodegenerative diseases, with its investigational drug CNM-Au8 demonstrating exceptional health benefits.

For ALS, CNM-Au8 showed a 68% decreased risk of all-cause mortality compared to historical controls and a median survival benefit of 198 days (6.5 months) over another regimen. In Parkinson's and MS patients, it increased NAD+/NADH ratios by an average of 10.4%, suggesting improved brain energy metabolism, and showed evidence of repair and remyelination. The company has an outstanding safety record, with over 700 patient-years of CNM-Au8 exposure without identified safety signals or serious adverse events. The Expanded Access Programs (EAPs) are offered at no cost to participants due to NIH funding, and leverage telehealth to reach individuals in remote areas, providing access to over 250 people with ALS who might otherwise be ineligible for trials. Clene has received a $45.1 million NIH grant to support a third EAP in ALS, demonstrating significant investment in health innovation. Clinical trials are conducted in accordance with Good Clinical Practice guidelines and ethical principles, with protocols approved by Human Research Ethics Committees. However, the company's risk transparency is limited by the presence of forward-looking statements and general cautions about differing actual results, and the lack of explicit details on data protection policies beyond general confidentiality. While the Columbia Suicide Severity Rating Scale (C-SSRS) is used as a safety endpoint, there is no evidence of broader mental health initiatives. The company holds patents but there is no information on its flexibility regarding global health needs. During the COVID-19 pandemic, OLE visits could be conducted remotely due to concerns or travel difficulties.

Fair Money & Economic Opportunity

Clene Inc. is a biopharmaceutical company focused on developing therapeutics for neurodegenerative diseases.

The 'Fair Money & Economic Opportunity' value assesses companies involved in lending, insuring, moving, or storing money. As Clene Inc.'s core business does not involve these financial services, all KPIs related to financial products, pricing, fees, lending, and customer financial outcomes are not applicable. The company does not offer lending or deposit services to consumers, nor does it generate or manage customer finance data. While Clene Inc. does engage in initiatives to broaden access to clinical trials for underserved patient populations and covers research-related costs for participants, these activities fall outside the scope of financial services as defined by this value.

Honest & Fair Business

Clene Inc. has a comprehensive whistleblower policy with a 24/7 ethics hotline for both US/Canada and international callers, and explicitly states that employees will not be subject to retaliation for good faith reports.

The company commits to protecting confidentiality to the extent possible. The Audit Committee Chair, who is independent of company management, is responsible for investigating reports. The company has had zero financial restatements in the past five years. Its Audit Committee is composed entirely of directors independent of company management, and conflicts of interest are prohibited unless approved by the Nominating and Governance Committee. The company has an FCPA-compliant anti-corruption policy that prohibits improper payments, bribes, and gifts to government officials, and bans donations to foreign charities and political contributions, and includes third-party due diligence requirements.

Kind to Animals

Clene Inc. explicitly states that it uses animals for product testing, with its lead asset CNM-Au8 having been shown to reduce neurodegeneration in animal models of diseases like ALS and MS.

This indicates that animal testing is conducted as part of their product development, likely due to legal or regulatory requirements for a biopharmaceutical company.

No War, No Weapons

During the 2024 reporting period, Clene Inc. identified gold as a conflict mineral used in its products.

The company sourced gold from one supplier and 45 smelters. All 45 smelters were cross-referenced against the RMI Conformant Smelter List without exception, indicating that 100% of its identified smelters met conflict-free standards.

Planet-Friendly Business

In 2023, Clene Inc. reported total greenhouse gas emissions of 3,975 metric tons, representing a 16.3% reduction from 2022.

The company sourced 47.2% of its operational energy from renewables in 2023. Clene Inc. conducted 12 nanotechnology environmental assessments in 2023. The company achieved a 100% compliance audit success rate in 2023 across 4 regulatory inspections, indicating zero violations.

Respect for Cultures & Communities

Clene Inc. provides an Ethics Hotline available 24/7 and other reporting channels through supervisors, the Audit Committee Chair, and the Nominating and Corporate Governance Committee.

Written reports can be submitted via mail or email to the Audit Committee Chair. These mechanisms are part of the company's Code of Business Conduct and Ethics, effective December 30, 2020, and are designed for reporting violations of the code.

Safe & Smart Tech

Clene Inc.'s privacy policy, last updated May 27, 2024, outlines data collection, use, and sharing.

Users have options to unsubscribe from email marketing and direct mail. They can also prevent online activity tracking and interest-based advertising through browser and mobile device settings or external industry opt-out tools. However, the company explicitly states it does not respond to 'Do Not Track' signals, indicating a limitation in user control. Australian residents are granted specific rights to access, rectify, erase, restrict processing, and obtain portable copies of their data, with a channel to direct complaints to the Australian Information Commissioner. For authentication, unique identification is assigned to individuals, passwords must be changed on first logon, and authentication is required for accessing Medium or High Risk Information Assets. The company conducts annual vulnerability assessments for all new and existing network-connected assets and monitors and applies security updates and patches. However, there is no specific timeframe provided for patching critical vulnerabilities. Cybersecurity incidents have been experienced, but to date, they have not had a material impact on financial condition or operations. The privacy policy indicates that personal information may be collected, processed, and stored in the United States and other countries, and while Australian residents have specific rights, the overall compliance program is not detailed as comprehensive or global.