Cassava Sciences Q1 2024 Financials and Phase 3 Simufilam Updates

Cassava Sciences, Inc., a biotechnology company headquartered in Austin, Texas, has announced its financial results for the first quarter ending March 31, 2024. The company, which focuses on developing treatments for Alzheimer’s disease, reported a net income of $25 million, a significant turnaround from a net loss of $24.3 million in the same period in 2023.

Operational cash usage for the first quarter was $19.1 million, with an expected cash use range for the first half of 2024 between $35 million and $45 million, primarily allocated towards their Alzheimer's clinical programs. Research and development expenditures were $16.2 million, a decrease from $22.1 million in the same quarter of the previous year, attributed mainly to the completion of patient screening and enrollment for their Phase 3 clinical program during the fall of 2023. General and administrative expenses also saw a reduction, down to $3.7 million from $4.4 million, influenced by higher legal fees being offset by approximately $3.0 million in insurance recoveries.

Cassava Sciences provided updates on its Phase 3 clinical program for simufilam, a drug aimed at treating Alzheimer's disease dementia. The program consists of two global, double-blind, randomized, placebo-controlled studies, RETHINK-ALZ and REFOCUS-ALZ, involving patients with mild-to-moderate Alzheimer's disease. These studies aim to assess the overall risk and benefit of administering 100 mg of simufilam twice daily compared to a placebo over periods of 52 weeks and 76 weeks, respectively.

The clinical trials, conducted across the United States, Canada, Puerto Rico, Australia, and South Korea, are fully enrolled. Approximately 1,900 patients are randomized across both studies, with about 800 in the RETHINK-ALZ and 1,100 in the REFOCUS-ALZ. The dropout rate for the studies is between 20% and 22%, which is typical for trials of this duration. As of the latest update, over 435 patients have completed the RETHINK-ALZ study, and over 300 have completed the REFOCUS-ALZ study, totaling over 735 patients who have finished their participation.

The Data Safety and Monitoring Board (DSMB), comprising independent clinical research experts, has conducted routine reviews of interim patient safety data from the Phase 3 studies. Meetings held in September 2023 and March 2024 resulted in recommendations to continue the studies as planned without any modifications.

The pre-specified efficacy outcomes for the Phase 3 trials include ADAS-Cog12, a cognitive scale, and ADCS-ADL, a functional scale, with iADRS combining scores from both. The data from these efficacy endpoints remain blinded with no interim analyses planned. The company expects to release top-line data for the RETHINK-ALZ trial by the end of 2024 and for the REFOCUS-ALZ trial by mid-2025.

Additionally, Cassava Sciences has initiated an open-label extension study, allowing patients who completed a Phase 3 study to access simufilam for up to one year at no cost. About 90% of eligible patients have opted into this extension, with over 655 patients enrolled to date.

Financially, Cassava Sciences had cash and cash equivalents of $124.2 million as of March 31, 2024, with no debt. The company received total gross proceeds of $126.3 million from the cash exercise of warrants, including approximately $104 million acquired in April and May 2024. The net income of $25 million was driven by a favorable change in the fair value of warrant liabilities, though this was partially offset by increased costs related to patient enrollment and conducting the Phase 3 clinical program.

The company completed a dividend distribution of common stock warrants in January 2024, allowing holders to purchase shares at an effective price of $22.00 per share. The deadline for warrant exercise was May 6, 2024, after which unexercised warrants were redeemed by the company for a nominal fee.

Simufilam, Cassava Sciences' proprietary oral drug candidate, targets altered filamin A protein in the brain to restore its normal function and shape, potentially aiding Alzheimer’s patients in achieving better health outcomes. The company retains exclusive global rights to its investigational products and related technologies without any royalty obligations to third parties.

Cassava Sciences, dedicated to neurodegenerative disease research, continues to push forward in its mission to develop treatments that stabilize critical proteins in the brain associated with conditions like Alzheimer’s disease.