AUSTIN, Texas - Cassava Sciences, Inc. (NASDAQ:SAVA), a biotech firm engaged in developing treatments for Alzheimer's, has released its third-quarter financial report and provided updates on its Phase 3 clinical trials. The company anticipates releasing top-line data from its RETHINK-ALZ trial, evaluating the safety and efficacy of the investigational drug simufilam, by the end of 2024.
The RETHINK-ALZ study, which has completed enrollment with approximately 800 patients, and the REFOCUS-ALZ study, with about 1,100 patients enrolled, are both in progress. These trials are assessing simufilam in individuals with mild-to-moderate Alzheimer's disease, with the primary outcomes focused on cognitive and functional scales. The Data and Safety Monitoring Board (DSMB) has recommended the continuation of both studies without modification.
Around 1,900 patients have been randomized across the two studies, with a drop-out rate of 21% for RETHINK-ALZ and 25% for REFOCUS-ALZ. The company reported that the last patient visit for RETHINK-ALZ occurred several weeks ago, with approximately 635 patients having completed the study. Over 550 patients have finished the REFOCUS-ALZ study.
Cassava Sciences also noted that a significant proportion of participants who completed the Phase 3 studies have entered the open-label extension study, designed to provide continued access to simufilam and to collect additional long-term data.
Financially, Cassava reported a net loss of $27.9 million or $0.58 per share for the third quarter ended September 30, 2024. This is compared to a net loss of $25.7 million, or $0.61 per share, during the same period in 2023. The company's cash and cash equivalents stood at $149.0 million, expected to fund operations into 2026. Research and development expenses decreased from the previous year, primarily due to the completion of patient enrollment in the Phase 3 clinical program.
Cassava Sciences plans to pay a $40 million SEC investigation settlement, which has been placed in escrow. The company estimates its year-end cash balance to range from $117 to $127 million.
The press release statement from Cassava Sciences serves as the basis for these updates, without any claims being endorsed regarding the investigational drug's efficacy or potential.
In other recent news, Cassava Sciences has seen significant developments. The company reported a first-quarter net income of $25 million, a remarkable turnaround from the net loss of $24.3 million during the same period last year. Cassava Sciences also recently agreed to a $40 million settlement with the U.S. Securities and Exchange Commission (SEC) over allegations of misleading statements regarding its Alzheimer's drug trial results.
Furthermore, the company's Alzheimer's drug trials received a third endorsement from the Data and Safety Monitoring Board (DSMB), allowing the continuation of its ongoing Phase 3 studies without modifications. The company also underwent leadership changes with the appointment of Richard Barry as CEO and Claude Nicaise, M.D. as Chairman of the Board. The company mourns the loss of long-serving board member Sanford "Sandy" Robertson, whose contributions were widely acknowledged.
Cassava Sciences extended its Alzheimer's drug trial, simufilam, by an additional 36 months for gathering more long-term data. Amidst these developments, the company 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 the recent developments for Cassava Sciences.
InvestingPro Insights
As Cassava Sciences (NASDAQ:SAVA) navigates through its critical Phase 3 clinical trials for simufilam, investors are closely watching the company's financial health and market performance. According to InvestingPro data, SAVA's market capitalization stands at $1.27 billion, reflecting the market's current valuation of the company's potential in the Alzheimer's treatment space.
Despite the reported net loss, InvestingPro Tips highlight that Cassava Sciences holds more cash than debt on its balance sheet, which aligns with the company's reported cash position of $149.0 million. This strong liquidity is crucial for funding ongoing clinical trials and operations into 2026, as mentioned in the article.
The company's financial strategy appears prudent, with InvestingPro data showing that liquid assets exceed short-term obligations. This financial cushion is particularly important as Cassava Sciences prepares to pay the $40 million SEC investigation settlement.
It's worth noting that while SAVA has shown a strong return over the last five years, InvestingPro Tips indicate that the stock price often moves in the opposite direction of the market. This volatility could be attributed to the high-stakes nature of Alzheimer's drug development and the pending clinical trial results.
Investors should be aware that Cassava Sciences is currently not profitable, with a negative P/E ratio of -82.93 for the last twelve months as of Q2 2024. Additionally, analysts do not anticipate the company to be profitable this year, which is typical for biotech companies in the late stages of drug development.
For those interested in a deeper analysis, InvestingPro offers 10 additional tips for SAVA, providing a more comprehensive view of the company's financial health and market position.
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