Better Health for All

The company's primary product, HEPZATO KIT, is a liver-directed treatment for unresectable hepatic metastases from uveal melanoma.

Clinical trials show an objective response rate (ORR) of 36.3%, significantly higher than the 5.5% ORR in historical controls, with a median overall survival of 20.5 months. The company's entire business is devoted to this product and its development for cancer treatment, indicating exceptional health benefits for a severe, rare cancer. However, the treatment carries significant safety risks. Serious adverse reactions occurred in 45% of patients, with 3.2% fatal adverse reactions. Grade 3 or 4 myelosuppression was observed in 68% of patients, including thrombocytopenia (55%), anemia (33%), and neutropenia (30%). The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) program due to potential serious risks like hemorrhage, hepatocellular injury, and thromboembolic events. For price accessibility, a copay assistance program offers a maximum benefit of $10,000 per calendar year, potentially reducing patient out-of-pocket costs to $0 for commercially insured US residents treated at REMS-certified facilities. This program aims to improve access for those in need. Regarding risk transparency, the company provides detailed prescribing information outlining contraindications, warnings, precautions, and adverse reactions. The FDA-mandated REMS program also ensures specific patient criteria and reporting requirements are in place to manage serious risks. However, the article on the REMS program primarily focuses on its structure and reporting, rather than providing comprehensive public data resources or setting new global standards for disclosure. Clinical trial data from the pivotal Phase 3 FOCUS study, which led to FDA approval, has been published in the *Annals of Surgical Oncology*, demonstrating transparency in reporting research outcomes. The copay assistance program is the only evidence of a health equity program, but no data is provided on its reach or impact on vulnerable populations, nor is there information on its funding as a percentage of revenue.

Fair Money & Economic Opportunity

Delcath Systems, Inc. operates in the pharmaceutical and medical device sectors, not as a financial institution.

As such, the company does not offer lending or deposit services to consumers, nor does it manage customer financial data or operate financial service access points. Therefore, all KPIs related to financial services, such as underserved client share, pricing fairness, exploitative fee exposure, inclusion initiatives, data accessibility, fair lending compliance, wealth building outcomes, profit reinvestment, financial literacy initiatives, debt burden ratio, geographic inclusion, and product simplicity, are not applicable to its core business model. The available evidence does not provide specific, quantifiable data points for these KPIs within the context of financial services.

Fair Pay & Worker Respect

The company and its subsidiaries are not party to a collective bargaining agreement, indicating 0% union coverage.

Employee reviews on Glassdoor show an average worker engagement score of 3.35/5 (67%). Delcath offers a comprehensive benefits package including health, vision, and dental insurance for employees and their families, as well as life, disability, and supplemental insurance options. An Employee Stock Purchase Plan (ESPP) is available, with 53 employees eligible as of March 10, 2022. The company laid off 21 of 60 employees (33%) after an FDA rejection, following previous layoffs of 20% of the workforce in June.

Honest & Fair Business

Delcath Systems has a comprehensive whistleblower policy, last reviewed March 1, 2022, which complies with Section 301 of the Sarbanes-Oxley Act of 2002 and Section 922 of the Dodd-Frank Act of 2010.

It encourages anonymous reporting via a secure ethics hotline and website, protects whistleblowers from retaliation, and outlines an investigation process involving the Audit Committee with authority to retain outside expertise. The company had a financial restatement for the six months ended June 30, 2001, and the cumulative period from inception to June 30, 2001, to include the estimated value of warrants issued for consulting services. Five out of six directors are independent according to Nasdaq listing rules. The company's Code of Ethics incorporates guidelines designed to deter wrongdoing and promote compliance with applicable laws, rules, and regulations. A loan agreement from August 6, 2021, includes a negative covenant that the Borrower will not take any action that would cause a violation of any anti-corruption law, including the Foreign Corrupt Practices Act and the United Kingdom Bribery Act, and an affirmative covenant to provide true, accurate, and complete information.

Kind to Animals

The provided financial report for Delcath Systems, Inc. explicitly states that it does not contain information regarding animal welfare, animal testing, or related topics.

Therefore, no evidence is available to assess the company against any of the 'Kind to Animals' KPIs.

Safe & Smart Tech

Delcath Systems, Inc. provides users with comprehensive rights over their personal data, including the right to be informed, receive a copy, rectify inaccurate data, complete incomplete information, erase personal data, restrict data processing, receive data in a structured format, and withdraw consent.

The company states it uses commercially reasonable means to protect personally identifiable information, storing it on computer servers with limited access in controlled facilities and in the cloud, and physical files in offices and archives. Delcath also states it collects personally identifiable information when voluntarily submitted and automatically collects non-personally identifiable information, processing data to comply with legal obligations, perform requested services, with consent, or for legitimate interests. The company received Medical Device Regulation (MDR) certification for its CHEMOSAT Hepatic Delivery System in Europe on February 28, 2022, under the new EU Medical Devices Regulation [2017/745/EU], and its PHP system is regulated by the United States Food and Drug Administration (FDA).

Zero Waste & Sustainable Products

No specific, quantitative data related to waste diversion, product recyclability, packaging sustainability, recycled content, single-use plastic reduction, take-back programs, circular design, waste reduction initiatives, hazardous waste management, product durability, repairability, waste audit frequency, zero waste certification, waste disposal violations, material efficiency, packaging-to-product ratio, waste reduction targets, supplier waste requirements, or customer waste education was provided in the articles.

The available information explicitly indicates a significant data gap regarding the company's sustainability practices in these areas, making it impossible to assess performance against the Zero Waste & Sustainable Products value.