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Cassava Sciences SAVA, a clinical-stage biotech focusing on developing novel products to detect and treat neurodegenerative diseases, such as Alzheimer’s disease (AD), is expected to report fourth-quarter earnings results soon.
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The Zacks Consensus Estimate for SAVA’s loss per share in the to-be-reported quarter is currently pegged at $1.58. The company currently does not generate any revenues.
Let's see how things have shaped up for the upcoming quarterly release.
Factors to Consider Regarding SAVA’s Q4 Earnings
In the absence of a marketed product, investors are advised to look forward to the company’s pipeline updates in the upcoming earnings call.
Please note that in November 2024, Cassava faced a massive setback after it reported that its lead and only pipeline drug, simufilam, failed to meet the primary endpoints in a late study for AD.
Cassava released top-line results from the RETHINK-ALZ study, which evaluated simufilam in patients with mild-to-moderate AD. Treatment with the drug failed to achieve a significant reduction in cognitive or functional decline in AD patients when compared to placebo over 52 weeks, as assessed by the ADAS-COG12 and ADCS-ADL scales. The study failed to meet any pre-specified secondary and exploratory biomarker endpoints, as well.
Based on the above study results, SAVA also decided to discontinue the phase III REFOCUS-ALZ study, which evaluated simufilam in AD patients over 76 weeks. It will also be discontinuing the open-label extension study on the drug.
In the past three months, the stock has plunged 89.8% compared with the industry’s 6.5% decline.
Image Source: Zacks Investment Research
Cassava is in the final stages of discontinuing the REFOCUS-ALZ study and anticipates releasing topline results in the late first quarter or early second quarter of 2025. Meanwhile, the company is carefully analyzing data from the RETHINK-ALZ study and intends to also incorporate findings from the REFOCUS-ALZ study into its assessment of future steps.
Cassava is currently left with its lead investigational diagnostic product candidate, SavaDx. Management believes that this candidate has the potential to become a novel way of detecting the presence of AD from a small blood sample.
In early January, SAVA announced plans to reduce its workforce by 33% in first-quarter 2025 as part of ongoing cost management efforts. Additionally, it will discontinue the planned biomarker analysis of plasma samples from past mid-stage studies. The workforce reduction is expected to result in a one-time cost of approximately $0.4 million in first-quarter 2025.