Cassava Sciences Stock Price, News & Analysis

Cassava Sciences (SAVA) has successfully completed an End-of-Phase 2 meeting with the FDA regarding simufilam, its Alzheimer’s disease candidate. The FDA agreed on key elements for a pivotal Phase 3 clinical program, set to start in the latter half of 2021. The Phase 3 studies will assess both disease-modifying effects and symptomatic improvement in approximately 1,600 Alzheimer’s patients. Key endpoints include ADAS-Cog and ADCS-ADL. Previous Phase 2 data showed promising results with no safety issues, setting a solid foundation for the upcoming trials.

Cassava Sciences (Nasdaq: SAVA) announced the closing of a direct offering of 4,081,633 shares of common stock at $49.00 per share, generating approximately $200 million in gross proceeds. After fees, the net proceeds are expected to be around $189.7 million, intended for working capital, general corporate purposes, and development of simufilam, its lead Alzheimer’s drug. The offering was conducted under an automatic shelf registration statement filed on February 10, 2021, with the SEC.

Cassava Sciences, Inc. (Nasdaq: SAVA) has announced a registered direct offering of 4,081,633 shares at $49.00 each, totaling approximately $200 million. The offering is set to close around February 12, 2021, pending customary conditions. Proceeds will be allocated for general corporate purposes and the development of simufilam, targeted for Alzheimer’s treatment. The offering is conducted under an automatic shelf registration statement filed with the SEC on February 10, 2021.

Cassava Sciences (Nasdaq: SAVA) announced progress in its Alzheimer’s disease programs, specifically the drug candidate simufilam. The company plans to expand an ongoing open-label clinical study, increasing enrollment to a total of 150 patients. They expect to initiate a Phase 3 program in the second half of 2021, following a successful meeting with the FDA. Key milestones include a second interim analysis and a Cognition Maintenance Study. Cassava anticipates using approximately $20-25 million in cash for operations in 2021, with about $93 million in cash available at year-end 2020.

Cassava Sciences, Inc. (Nasdaq: SAVA) announced the appointment of James Kupiec, MD as Chief Clinical Development Officer to spearhead the Phase 3 development of simufilam, an investigational drug for Alzheimer’s disease. Dr. Kupiec brings over 30 years of experience from leading firms like Pfizer and Sanofi. The company aims to advance its clinical pipeline and collaborate with research leaders and regulators. Alzheimer’s affects approximately 5.8 million people in the U.S., highlighting the urgency for innovative treatments like simufilam, which aims to restore neuron function disrupted by altered filamin A.

Cassava Sciences, Inc. (Nasdaq: SAVA) announces that the World Health Organization has advised the United States Adopted Names Council to change the name of its lead drug candidate for Alzheimer’s disease to simufilam. This decision was made to avoid trademark conflicts with another drug available in the Far East. The USAN has accepted this name change, ensuring that all future references to the Alzheimer’s drug will be under the name simufilam. This indicates progress in the drug's development and branding for market readiness.

Cassava Sciences, Inc. (Nasdaq: SAVA) has announced a public offering of 9,375,000 shares of its common stock at a price of $8.00 per share, aimed at raising approximately $75 million for its Phase 3 clinical program of sumifilam for Alzheimer’s disease. An additional option allows underwriters to purchase up to 1,406,250 shares. The offering is expected to close on November 17, 2020, pending customary conditions. Proceeds will support research and general corporate purposes as part of the company’s strategic plan in neurodegenerative conditions.

Cassava Sciences (Nasdaq: SAVA) announced a proposed underwritten public offering of its common stock, subject to market conditions. The offering will include a 30-day option for underwriters to purchase an additional 15% of the shares. Proceeds are intended to fund a Phase 3 clinical program for sumifilam, their lead candidate for Alzheimer's disease, as well as research and general corporate purposes. Cantor Fitzgerald & Co. is managing the offering. The securities are registered under a previously declared effective shelf registration statement.

Cassava Sciences, Inc. (SAVA) reported a net loss of $1.4 million for Q3 2020, or $0.06 per share, an increase from a loss of $0.7 million ($0.04 per share) in Q3 2019. Total cash and cash equivalents stand at $24.1 million, up from $23.1 million at the end of 2019, with no debt. Net cash used in operations for the first nine months of 2020 hit $4.2 million, and the company expects to end the year with approximately $5.0 million in cash usage. R&D expenses rose to $0.4 million due to decreased NIH grant reimbursements.