Better Health for All

Cassava Sciences' lead drug candidate, simufilam for Alzheimer's disease, failed to show significant benefit in its two Phase 3 trials (RETHINK-ALZ and REFOCUS-ALZ) and will be phased out by Q2 2025.

The company is initiating preclinical studies for TSC-related epilepsy and developing a diagnostic test, SavaDx, in mid-stage studies. While the drug demonstrated an overall favorable safety profile, the REFOCUS-ALZ trial reported serious adverse events (SAEs) in 11.5% (100mg dose) and 16.2% (50mg dose) of simufilam participants, compared to 12.1% in the placebo group. Adverse events leading to discontinuation were 8.6% and 9.0% for simufilam groups, versus 4.6% for placebo. Deaths were 0.5% and 1.6% for simufilam groups, versus 0.8% for placebo. The company has no product revenue. Cassava paid a $40 million settlement to the SEC for negligence-based disclosure charges related to misleading statements about its 2020 Phase 2b clinical trial results. A neuroscientist linked to the drug's development was indicted for allegedly defrauding the NIH of $16 million in grant funding. The SEC also alleged manipulation of Phase 2b trial data, including unblinding approximately one-third of patients and removing about 40% of patients with observed improvement from the data. R&D expenses were $16.2 million in Q1 2024, down from $22.1 million in Q1 2023, and are expected to be $35-$45 million for H1 2024, including the SEC penalty.

Fair Trade & Ethical Sourcing

The company being assessed is SAVA.US (Cassava Sciences, Inc.), a clinical-stage biotechnology company.

Articles sourced from 'www.cassavatechnologies.com' refer to 'Cassava Technologies,' which appears to be a distinct entity. Therefore, data from these articles is not applicable to Cassava Sciences, Inc. The remaining articles (from 'www.cassavasciences.com') provide no specific, quantitative evidence for any of the 'Fair Trade & Ethical Sourcing' KPIs, such as fair trade certifications, supplier audit frequency, forced or child labor incidents, supply chain traceability, remediation speed for supplier violations, ethical clause coverage in supplier contracts, materials risk index, or supplier diversity spend.

Honest & Fair Business

No specific, concrete data points were provided in the articles for any of the KPIs.

While one article mentioned the existence of a whistleblower policy, it explicitly stated that specific details such as hotline statistics, reporting mechanisms, or protection provisions were not provided. Without these specific details, it is not possible to map the information to any of the defined quantitative or qualitative tiers in the rubric, which require more granular evidence of policy strength, enforcement, or outcomes. Therefore, all KPIs are omitted.

Kind to Animals

Cassava Sciences conducts preclinical studies using animal models, specifically mice, for drug development, including safety pharmacology, toxicology, genotoxicity, and efficacy, in support of Investigational New Drug (IND) submissions to the FDA.

The company also licensed a patent from Yale University based on research that included animal models. While in vitro studies are mentioned, animal tests appear to dominate for efficacy and safety, indicating alternative assays are used sporadically. The company does not explicitly state an animal testing policy, but routine animal testing is a core part of its drug development process for regulatory submissions. There is no information on the number of animals used, which, in the absence of any data, maps to the lowest tier. The company's development activity related to SavaDx accounts for less than 1% of its research budget. Cassava Sciences plans to conduct preclinical studies in collaboration with the TSC Alliance to further evaluate simufilam’s potential as a treatment for TSC-related seizures, and a study was conducted in collaboration with the TSC Alliance and PsychoGenics, Inc., which indicates participation in industry consortia working on animal-free testing methods with minimal contributions.

Respect for Cultures & Communities

The provided articles focus on Cassava Sciences' financial performance, clinical trial progress for Alzheimer's drug candidates, and workforce reduction.

No specific, concrete data points or information related to the company's engagement with local or indigenous communities, cultural preservation efforts, community investment, or any other aspect of 'Respect for Cultures & Communities' were found.

Safe & Smart Tech

The provided articles focus on financial and research and development updates for Cassava Sciences, Inc.

No specific data or information related to data breaches, cybersecurity investment, privacy certifications, AI ethics, encryption, data minimization, or any other 'Safe & Smart Tech' KPIs was found. Therefore, no assessment can be made against these metrics.