{"id":479563,"date":"2021-04-21T08:33:12","date_gmt":"2021-04-21T12:33:12","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/cassava-sciences-reports-first-quarter-2021-financial-results-and-announces-guidance-on-clinical-data-release\/"},"modified":"2021-04-21T08:33:12","modified_gmt":"2021-04-21T12:33:12","slug":"cassava-sciences-reports-first-quarter-2021-financial-results-and-announces-guidance-on-clinical-data-release","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cassava-sciences-reports-first-quarter-2021-financial-results-and-announces-guidance-on-clinical-data-release\/","title":{"rendered":"Cassava Sciences Reports First Quarter 2021 Financial Results and Announces Guidance on Clinical Data Release"},"content":{"rendered":"
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\n – 9 Month Interim Analysis of Open-label Study to be Presented at\u00a0<\/strong>
\n a Major Scientific Conference in July 2021 as an Oral Presentation –<\/strong>\n <\/p>\n

\n – Initiation of Pivotal Phase 3 Program Remains On-track for 2<\/strong>
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\n nd<\/strong>
\n <\/sup>
\n Half 2021 –<\/strong>\n <\/p>\n

\n – Initiation of Cognition Maintenance Study On-track for June 2021 –<\/strong>\n <\/p>\n

\n – Cash and cash equivalents were $282.2 million at March 31, 2021 –<\/strong>\n <\/p>\n

AUSTIN, Texas, April 21, 2021 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer\u2019s 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\u2019s lead drug candidate to treat Alzheimer\u2019s disease.<\/p>\n

\u201cAlzheimer\u2019s is a progressive disease, so a patient\u2019s cognition is expected to worsen over time,\u201d said Remi Barbier, President & CEO. \u201cPatients\u2019 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\u2019s mechanism of action. Eventually, we\u2019d like this drug candidate to benefit cognition for a year or longer.\u201d<\/p>\n

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<\/sup> at the 2021 <\/em>Alzheimer\u2019s Association International Conference<\/em> (AAIC). AAIC\u2019s scientific committee has invited the Company\u2019s scientists to present the dataset as an oral presentation.<\/p>\n

\n About the Open-label Study with Simufilam
<\/strong>In March 2020, Cassava Sciences initiated a long-term, open-label study to evaluate simufilam in patients with Alzheimer\u2019s disease. This study is funded by a research grant award from the National Institutes of Health (NIH). The open-label study\u00a0is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice-daily for 12 months or longer in patients with Alzheimer\u2019s disease. Another study objective is to measure changes in cognition on ADAS-Cog, a standard test of cognition in Alzheimer\u2019s disease. The study\u2019s clinical protocol has pre-specified cognition measurements at 6, 9 and 12 months.<\/p>\n

The study\u2019s target enrollment is approximately 150\u00a0subjects with mild-to-moderate Alzheimer\u2019s disease (recently increased by 50 subjects). One-hundred subjects have enrolled in this study across multiple clinical sites in the U.S. and Canada.<\/p>\n

On February\u00a02, 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\u2019 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.<\/p>\n

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.<\/p>\n

\n About the Cognition Maintenance Study (CMS)<\/strong>
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In June 2021, Cassava Sciences plans to initiate a double-blind, randomized, placebo-controlled study in patients with Alzheimer\u2019s disease. Patients who have completed at least one year of open-label treatment with simufilam qualify to enroll in the Cognition Maintenance Study<\/em> (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\u2019s effects on cognition in Alzheimer\u2019s patients who continue with drug treatment versus patients who discontinue drug treatment.<\/p>\n

\n About the Phase 3 Clinical Program<\/strong>
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Cassava Sciences plans to initiate a Phase 3 program of simufilam in Alzheimer\u2019s 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\u2019s disease dementia.<\/p>\n

Cassava Sciences\u2019 first Phase 3 study is designed to evaluate disease-modifying<\/em> effects of simufilam in Alzheimer\u2019s 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\u2019s disease.<\/p>\n

Cassava Sciences\u2019 second Phase 3 study is designed to evaluate symptomatic improvement<\/em> in Alzheimer\u2019s 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.<\/p>\n

\n Slide Deck<\/strong>
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Cassava Sciences\u2019 latest corporate presentation is available on its website under the Investors\/Presentations page: https:\/\/www.CassavaSciences.com<\/a><\/p>\n

\n Financial Results for First Quarter 2021<\/strong>
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Net loss was $3.5 million, or $0.09 per share, compared to a net loss of $1.2 million, or $0.05 per share, for the same period in 2020. Net cash used in operations was $2.3 million during the first quarter of 2021.<\/p>\n

Net cash use for operations for full-year 2021 is expected to be approximately $20 to $25 million. Cash and cash equivalents were $282.2 million as of March 31, 2021, with no debt.<\/p>\n

\n Financial Highlights for First Quarter 2021<\/strong>\n <\/p>\n