Cassava Sciences Q2 2024 Financial Results and Updates

Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology firm pioneering a novel treatment for Alzheimer’s disease, has released its financial results for the second quarter ending June 30, 2024. The company reported a net income of $6.2 million, a significant turnaround from a net loss of $26.4 million during the same period in 2023. Net cash used in operations during the first half of 2024 was $37.4 million, aligning with earlier projections. The anticipated net cash usage for the second half of 2024 stands between $80 to $90 million, which encompasses an estimated $40 million loss contingency related to ongoing discussions to resolve an SEC investigation.

Rick Barry, Cassava’s Executive Chairman, stated, "We have made significant progress over the last few months." He lauded the efforts of the Cassava Clinical Operations team and their partner, Premier Research, for executing the Phase 3 program effectively. Barry noted the successful closing of the warrant program earlier this quarter, generating over $123 million in net equity capital, thereby strengthening the company's financial position. This liquidity is expected to support the company well beyond the Phase 3 trial readouts.

Cassava’s Phase 3 clinical program involves two global, double-blind, randomized, placebo-controlled studies to evaluate the safety and efficacy of simufilam, an oral drug candidate, in patients with mild-to-moderate Alzheimer’s disease. The first study, RETHINK-ALZ, assesses 100 mg tablets of simufilam versus placebo over 52 weeks. The second study, REFOCUS-ALZ, evaluates both 100 mg and 50 mg tablets versus placebo over 76 weeks. Clinical sites for these studies are spread across the United States, Canada, Puerto Rico, Australia, and South Korea.

Patient enrollment for both Phase 3 studies is complete, with approximately 1,900 patients randomized. The RETHINK-ALZ study has about 800 participants, while the REFOCUS-ALZ study involves around 1,100 participants. The dropout rate for these studies ranges from 20% to 23%, consistent with expectations for trials of this length. Over 555 patients have completed the RETHINK-ALZ study, and more than 420 have completed the REFOCUS-ALZ study, totaling over 975 completers.

The Data and Safety Monitoring Board (DSMB), comprising independent clinical research experts, has periodically reviewed interim patient safety data and recommended the continuation of both studies without modification. No interim analyses on efficacy outcomes are planned, with top-line data readouts expected by the end of 2024 for the RETHINK-ALZ study, and by mid-2025 for the REFOCUS-ALZ study.

An open-label extension study is also underway to provide no-cost access to simufilam for Alzheimer’s patients who have completed a Phase 3 study and meet other criteria. Approximately 89% of eligible patients have entered this extension study, which aims to continue for up to 36 months or until a new drug application for simufilam is reviewed by the FDA. The extension study will also include cognition and plasma biomarker monitoring to gather additional long-term data on the drug's potential impact.

Financially, as of June 30, 2024, Cassava had $207.3 million in cash and cash equivalents, with no debt. The cash balance includes $126.3 million from the exercise of common stock warrants, with $104.0 million received in the second quarter alone. The company’s net income for the second quarter of 2024 was influenced by a change in the fair value of warrant liabilities, partially offset by the estimated $40 million loss contingency related to the SEC investigation and costs associated with the Phase 3 clinical program.

R&D expenses for the second quarter were $15.2 million, down from $25.0 million during the same period in 2023, mainly due to the completion of patient screening and enrollment for the Phase 3 program in 2023. General and administrative expenses rose sharply to $46.2 million from $3.8 million in 2023, primarily due to the estimated loss contingency and increased costs related to stock-based compensation, new grants, and legal expenses.

Cassava Sciences remains focused on advancing its mission to develop a best-in-class therapy for Alzheimer’s patients, leveraging its robust financial health and ongoing clinical trials.