Earnings release
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EXHIBIT 99.1 Cassava Sciences Reports First Quarter 2021 Financial Results and Announces Guidance on Clinical Data Release - 9 Month Interim Analysis of Open - label Study to be Presented at a Major Scientific Conference in July 2021 as an Oral Presentation - Initiation of Pivotal Phase 3 Program Remains On - track for 2nd Half 2021 - Initiation of Cognition Maintenance Study On - track for June 2021 - - Cash and cash equivalents were $ 282.2 million at March 31 , 2021 - AUSTIN , Texas , April 21 , 2021 ( GLOBE NEWSWIRE ) Cassava Sciences , Inc. ( Nasdaq : SAVA ) , a clinical - stage biotechnology company focused on Alzheimer's disease , today announced financial results for the first quarter ended March 31 , 2021 and guidance regarding the release of new clinical data with simufilam . Simufilam is the Company's lead drug candidate to treat Alzheimer's disease . " Alzheimer's is a progressive disease , so a patient's cognition is expected to worsen over time , " said Remi Barbier , President & CEO . " Patients ' cognition scores actually improved following 6 months of open - label treatment with simufilam . Showing similar drug effects following 9 months of open - label treatment would be remarkable , yet consistent with simufilam's mechanism of action . Eventually , we'd like this drug candidate to benefit cognition for a year or longer . " In July 2021 , Cassava Sciences plans to announce results of a pre - specified interim analysis that summarizes safety and cognition data on approximately the first 50 subjects to complete at least 9 months of open - label drug treatment . The Company will present these data July 26 - 29th at the 2021 Alzheimer's Association International Conference ( AAIC ) . AAIC's scientific committee has invited the Company's scientists to present the dataset as an oral presentation . About the Open - label Study with Simufilam In March 2020 , Cassava Sciences initiated a long - term , open - label study to evaluate simufilam in patients with Alzheimer's disease . This study is funded by a research grant award from the National Institutes of Health ( NIH ) . The open - label study is intended to monitor the long - term safety and tolerability of simufilam 100 mg twice - daily for 12 months or longer in patients with Alzheimer's disease . Another study objective is to measure changes in cognition on ADAS - Cog , a standard test of cognition in Alzheimer's disease . The study's clinical protocol has pre - specified cognition measurements at 6 , 9 and 12 months . The study's target enrollment is approximately 150 subjects with mild - to - moderate Alzheimer's disease ( recently increased by 50 subjects ) . One - hundred subjects have enrolled in this study across multiple clinical sites in the U.S. and Canada . On February 2 , 2021 , Cassava Sciences announced positive results of a first interim analysis that summarizes clinical data on the first 50 subjects to complete 6 months of open - label treatment . Patients ' cognition scores improved from baseline following 6 months of simufilam treatment , with no safety issues . Six months of simufilam treatment improved cognition scores by 1.6 points on ADAS - Cog11 , a 10 % mean improvement from baseline to month 6 . In September 2021 , Cassava Sciences plans to announce results of an interim analysis that summarizes safety and cognition data on approximately the first 50 subjects to complete at least 12 months of open - label drug treatment . About the Cognition Maintenance Study ( CMS ) In June 2021 , Cassava Sciences plans to initiate a double - blind , randomized , placebo - controlled study in patients with Alzheimer's disease . Patients who have completed at least one year of open - label treatment with simufilam qualify to enroll in the Cognition Maintenance Study ( CMS ) . Study subjects in the CMS will be randomized ( 1 : 1 ) to simufilam or placebo for six months . The CMS is designed to compare simufilam's effects on cognition in Alzheimer's patients who continue with drug treatment versus patients who discontinue drug treatment . About the Phase 3 Clinical Program Cassava Sciences plans to initiate a Phase 3 program of simufilam in Alzheimer's disease in the second half of 2021. The Phase 3 program consists of two large , double - blind , randomized , placebo - controlled studies in patients with mild - to - moderate Alzheimer's disease dementia . Cassava Sciences ' first Phase 3 study is designed to evaluate disease - modifying effects of simufilam in Alzheimer's disease . The goal is to demonstrate a slower rate of decline in cognition and health function in subjects treated with simufilam compared to placebo . Approximately 1,000 subjects to be enrolled , randomized ( 1 : 1 : 1 ) to simufilam 100 mg , 50 mg or placebo BID , and treated for 18 months . The co - primary efficacy endpoints are ADAS - Cog , a cognitive scale , and ADCS - ADL , a functional scale , both widely used clinical tools in trials of Alzheimer's disease . Cassava Sciences ' second Phase 3 study is designed to evaluate symptomatic improvement in Alzheimer's disease . The goal is to demonstrate improved cognition and health function in subjects treated with simufilam compared to placebo . Approximately 600 subjects to be enrolled , randomized ( 1 : 1 ) to simufilam 100 mg or placebo BID , and treated for 12 months . The co - primary efficacy endpoints are ADAS - Cog , a cognitive scale , and ADCS - ADL , a functional scale .