Cassava Sciences Q3 2024 Financial and Operating Results Report

Cassava Sciences, Inc., a clinical-stage biotechnology company based in Austin, Texas, has announced financial results for the third quarter ending September 30, 2024. The company is primarily focused on developing innovative therapies for Alzheimer's disease, with their lead investigational drug, simufilam, undergoing two Phase 3 trials.

The two Phase 3 trials, RETHINK-ALZ and REFOCUS-ALZ, are designed to evaluate the safety and efficacy of simufilam in patients with mild-to-moderate Alzheimer's disease. The RETHINK-ALZ trial involves administering 100 mg of simufilam twice daily over 52 weeks, while the REFOCUS-ALZ trial tests both 100 mg and 50 mg doses over 76 weeks. Clinical sites for these studies are spread across the United States, Canada, Puerto Rico, Australia, and South Korea.

Both Phase 3 trials have reached full enrollment, with around 1,900 patients participating. Approximately 800 patients are involved in the RETHINK-ALZ trial, and around 1,100 in the REFOCUS-ALZ trial. Most participants, about 90%, are from clinical sites in the U.S. and Canada. The dropout rate is 21% for RETHINK-ALZ and 25% for REFOCUS-ALZ, which aligns with expectations for such studies. The RETHINK-ALZ trial has recently completed its final patient visits, with approximately 635 patients completing the trial. The REFOCUS-ALZ trial has seen over 550 completions, totaling more than 1,185 patients finished in both studies.

An independent Data and Safety Monitoring Board (DSMB) reviews interim safety data periodically. The DSMB's recent meeting in September 2024 recommended the continuation of both trials as planned, consistent with their previous recommendations in September 2023 and March 2024.

Efficacy outcomes for the trials are being measured using the Alzheimer’s Disease Assessment Scale-Cognitive subscale 12 (ADAS-Cog12) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living subscale (ADCS-ADL). These efficacy data remain blinded, with no interim analyses planned. Top-line data for the RETHINK-ALZ trial are expected before the end of 2024, while results from the REFOCUS-ALZ trial are anticipated around mid-2025.

An open-label extension (OLE) study has been initiated to provide continued access to simufilam for patients completing the Phase 3 trials. Approximately 88% of patients transitioning from the Phase 3 studies have entered the OLE study, with over 1,040 participants enrolled. This study is intended to run for up to 36 months or until simufilam receives FDA approval. The OLE study will also include cognition and plasma biomarker monitoring to gather additional long-term data on simufilam's impact.

Financially, as of September 30, 2024, Cassava Sciences reported $149.0 million in cash and cash equivalents, supporting operations into 2026. The company reported a net loss of $27.9 million or $0.58 per share for the third quarter, compared to a net loss of $25.7 million, or $0.61 per share, for the same period in 2023. Net cash used in operations during the first nine months of 2024 was $55.7 million. For the second half of 2024, the company expects operational cash use to be between $40 to $50 million, consistent with previous guidance. Additionally, a $40 million settlement related to an SEC investigation has been placed in escrow.

Research and development (R&D) expenses were $17.7 million, down from $23.6 million in the same period in 2023. This decrease is mainly due to the completion of patient screening and enrollment for the Phase 3 trials. General and administrative (G&A) expenses rose significantly to $12.9 million from $4.3 million in 2023, primarily due to higher legal expenses, increased compensation costs, and stock-based compensation expenses.

Cassava Sciences, Inc. continues to advance its mission of developing treatments for neurodegenerative diseases, with simufilam showing promise as their leading candidate for Alzheimer’s disease.