AUSTIN, Texas - Cassava Sciences, Inc. (NASDAQ:SAVA), a clinical-stage biotech company, announced today that an independent Data and Safety Monitoring Board (DSMB) has completed a third interim safety review of its Alzheimer's disease drug candidate, simufilam, and recommended the continuation of its two ongoing Phase 3 studies without any modifications. The DSMB, comprising independent clinical research experts, periodically assesses patient safety data from the trials.
This latest safety review marks the third endorsement by the DSMB for the trials to proceed as planned. The first Phase 3 trial, with a 52-week treatment period, randomized 804 patients, and top-line results are expected by the end of 2024. The second trial, with a 76-week treatment period, includes 1,125 patients, with results anticipated around mid-year 2025.
Simufilam, a small molecule drug candidate, is currently being tested in patients with mild-to-moderate Alzheimer's disease dementia. It aims to target a specific site on filamin A, a protein believed to be involved in the disease's progression. To date, over 1,900 patients have been enrolled in the trials across multiple countries, including the U.S., Puerto Rico, Canada, Australia, and South Korea.
The company previously announced in October 2023 that interim safety MRI data suggested simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities (ARIA). The final safety data for simufilam is expected at the conclusion of the Phase 3 program.
Cassava Sciences is conducting these studies in collaboration with Premier Research International, a global contract research organization. As the trials continue, the biotech firm remains exclusively responsible for its investigational product candidates and related technologies worldwide.
The information in this article is based on a press release statement from Cassava Sciences, Inc.
In other recent news, Cassava Sciences has seen significant developments. The company reported a first-quarter net income of $25 million, marking a substantial improvement from the net loss of $24.3 million during the same period last year. This financial turnaround was attributed to changes in the fair value of warrant liabilities. The company also announced the appointment of Richard Barry as CEO, alongside Claude Nicaise, M.D., who takes on the role of Chairman of the Board. In addition, Cassava Sciences is mourning the passing of Sanford "Sandy" Robertson, a long-serving member of its Board of Directors.
The company also extended its Alzheimer's drug trial, simufilam, by an additional 36 months for gathering more long-term data. Amidst these developments, Cassava Sciences faced legal challenges with a former consultant indicted for allegedly making false statements in grant applications. Analysts' views on the company varied, with H.C. Wainwright maintaining a Neutral rating and revising its price target for Cassava Sciences to $131.00, while Jones Trading downgraded the company's stock from Buy to Hold due to ongoing legal investigations. These are among the recent developments for Cassava Sciences.
InvestingPro Insights
As Cassava Sciences, Inc. (NASDAQ:SAVA) continues its clinical trials for simufilam, its potential in the Alzheimer's disease market is under close scrutiny by investors. Despite the DSMB's positive safety reviews, financial metrics and market performance paint a complex picture for the company. Cassava Sciences holds a market capitalization of approximately $1.3 billion, reflecting investor interest in its innovative approach to Alzheimer's treatment. However, the company's financial health shows some concerns, with a negative P/E ratio of -76.56, indicating that it is not currently profitable.
InvestingPro data reveals that Cassava Sciences has not been profitable over the last twelve months, with an operating income adjusted to around -$132.0 million. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year. This tip is particularly relevant as it provides insight into the company's short-term financial expectations amidst its ongoing clinical trials.
Another key metric for potential investors is the stock's price volatility. Cassava Sciences' stock has experienced a significant hit over the last week, with a 1 Week Price Total Return of -13.72%. This is supported by an InvestingPro Tip highlighting the stock's high price volatility, which may attract traders looking for short-term movements but could be a concern for long-term investors seeking stability.
Despite these challenges, the company's stock has shown resilience with a strong return over the last year of 53.96%. Investors may also find solace in the fact that Cassava Sciences holds more cash than debt on its balance sheet, as per another InvestingPro Tip, suggesting a degree of financial flexibility.
For those interested in a deeper analysis, InvestingPro offers additional tips on Cassava Sciences, with a total of 15 tips available on their platform, providing a comprehensive view of the company's financial health and stock performance.
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