AUSTIN, Texas - Cassava Sciences Inc. (NASDAQ:SAVA) announced today that it will extend its open-label extension trials for the Alzheimer's drug simufilam by up to an additional 36 months. This extension allows participants from the company's completed Phase 2 and ongoing Phase 3 studies to continue receiving the drug if they choose.
The decision to extend the trials aims to bridge the treatment gap for patients until the results of the placebo-controlled Phase 3 trials are reported to regulatory authorities. Cassava also plans to integrate cognition and plasma biomarker monitoring into these extension trials to collect more long-term data on simufilam's effects.
Around 89% of patients in Cassava's Phase 3 studies have opted to continue treatment with simufilam after the blinded portion of the trials. Those who had completed the open-label Phase 3 extension with no further treatment option will now have the opportunity to re-enroll.
Cassava is currently conducting two key Phase 3 studies: RETHINK-ALZ, a 52-week trial, and REFOCUS-ALZ, a 76-week trial. The trials, which involve dosages of 100 mg and 50 mg of simufilam, are being conducted across multiple international sites. Top-line results for RETHINK-ALZ are expected by the end of 2024, with results for REFOCUS-ALZ anticipated around mid-2025.
The open-label extension studies are designed to provide continued no-cost access to simufilam for eligible Alzheimer's patients who have completed prior phases of the trial. Participation in the extension is at the discretion of each clinical investigational site.
In other recent news, Cassava Sciences has been the center of numerous developments. The company reported a profitable first quarter, with a net income of $25 million, a significant turnaround from the net loss of $24.3 million in the same period last year. This financial improvement was attributed to changes in the fair value of warrant liabilities, despite increased costs related to ongoing clinical trials for its Alzheimer's disease drug candidate, simufilam.
Cassava Sciences also disclosed that a former consultant, Dr. Hoau-Yan Wang, was indicted by a federal grand jury for allegedly making false statements in grant applications related to the early development phases of simufilam. Despite this, the company continues with its Phase 3 clinical trials for simufilam, expected to provide top-line results by the end of 2024 and mid-2025.
Furthermore, amidst legal challenges and significant changes to its management team, the company maintained a Neutral rating from H.C. Wainwright. Jones Trading, however, downgraded Cassava Sciences' stock from Buy to Hold due to ongoing investigations by the Department of Justice and the Securities and Exchange Commission.
H.C. Wainwright also revised its price target for Cassava Sciences to $131.00, up from the previous $124.00, following the company's first-quarter financial results.
InvestingPro Insights
As Cassava Sciences (NASDAQ:SAVA) continues to make strides in its Alzheimer's drug trials, investors and stakeholders are closely monitoring the company's financial health and stock performance. Recent data from InvestingPro offers a snapshot of the company's current market standing.
With a market capitalization of approximately $864.53 million, Cassava Sciences is navigating the biotech landscape with a notable cash position, holding more cash than debt on its balance sheet, an InvestingPro Tip that may reassure investors about the company's financial stability in the short term. This is particularly relevant as the company embarks on extended clinical trials, which can be capital-intensive endeavors.
The stock has experienced a significant return over the last week, with a 49.54% increase, and over the last month, it has seen a 45.91% rise. This volatility may reflect investor optimism around the extended trial announcement or other market factors. However, it's worth noting that the stock price often moves in the opposite direction of the market, an InvestingPro Tip that suggests Cassava's share price may not always align with broader market trends.
In terms of profitability, analysts do not anticipate Cassava Sciences to be profitable this year, and the company has not been profitable over the last twelve months. This is underscored by a negative operating income of $99.38 million for the last twelve months as of Q1 2024. Additionally, the company's Price / Book ratio stands at 11.0, indicating that the stock is trading at a high multiple compared to the company’s book value.
For investors seeking more in-depth analysis, there are additional InvestingPro Tips available for Cassava Sciences, which can be accessed by visiting https://www.investing.com/pro/SAVA. And for those interested in subscribing to InvestingPro for more exclusive insights, use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.