Articles from Cassava Sciences, Inc.

Topline data from Phase 3 REFOCUS-ALZ study of simufilam in patients with mild-to-moderate Alzheimer’s disease expected late first-quarter/early second-quarter 2025

Simufilam did not show a significant reduction in cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease in the ReThink-ALZ Phase 3 study

Webcast planned for Monday, November 25th at 8:00 AM ET

Ms. Nassif brings an extensive track record of successfully developing commercial strategies for multiple FDA-approved drugs

AUSTIN, Texas, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on developing a novel treatment for Alzheimer’s disease, today reported financial results for the third quarter ended September 30, 2024.

Conference call and webcast to begin at 8:30 AM ET

AUSTIN, Texas, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (“Cassava” or the “Company”) (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced that it has reached a settlement with the U.S. Securities and Exchange Commission (“SEC”) of negligence-based disclosure charges that resolve a previously-disclosed SEC investigation into statements made by the Company pertaining to the results of its 2020 Phase 2b clinical trial of simufilam and related matters. Two former senior employees of the Company also settled negligence-based disclosure charges brought by the SEC.

AUSTIN, Texas, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the completion of a third interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer’s disease. A routine, scheduled meeting of a Data and Safety Monitoring Board (DSMB) resulted in a recommendation that both of Cassava Sciences’ on-going Phase 3 studies continue as planned, without modification.

Claude Nicaise, M.D. appointed Chairman of the Board

AUSTIN, Texas, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, announced today that it has been invited to present at the H.C. Wainwright 26th Annual Global Investment Conference, being held in New York.

AUSTIN, Texas, Aug. 08, 2024 (GLOBE NEWSWIRE) --  Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on a novel treatment for Alzheimer’s disease, today reported financial results for the second quarter ended June 30, 2024. Net income was $6.2 million compared to a net loss of $26.4 million for the same period in 2023. Net cash used in operations was $37.4 million during the first half of 2024, consistent with previous guidance. Net cash use in second half 2024 is expected to be $80 to $90 million, which includes an estimated $40 million loss contingency related to advanced discussions to resolve the SEC’s investigation of the Company recorded in the second quarter.

AUSTIN, Texas, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) today reflected on the passing of long-time board member Sanford Robertson.

AUSTIN, Texas, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, announced today that it will hold a conference call on Thursday, August 8th at 8:30 a.m. Eastern Time.

AUSTIN, Texas, July 30, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) today announced that the Company will extend by up to an additional 36 months each of the open-label extension trials in its ongoing Phase 2 and Phase 3 clinical programs. These amendments to the protocols will allow patients who have previously participated in a randomized trial of simufilam in Alzheimer’s disease, if they desire, to continue open-label treatment with simufilam. This expansion of the open-label extension trials offers a bridge for any gap between patients ending treatment in a clinical trial and the Company reporting to regulatory authorities the results of the ongoing, randomized, placebo-controlled Phase 3 trials. The open-label extension can continue for up to 36 months or until a new drug application for simufilam has been reviewed by FDA.

AUSTIN, Texas, July 17, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) today announced that the Board of Directors has appointed Richard (Rick) Barry as Executive Chairman of the Board and as the Company’s principal executive officer, effective immediately. The Company is undertaking a search for a new permanent CEO.

AUSTIN, Texas, June 28, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), reported it has learned today that a federal grand jury returned an indictment charging Hoau-Yan Wang for allegedly defrauding the U.S. National Institutes of Health (NIH). Hoau-Yan Wang was a tenured medical professor at a public university’s medical school as well as a former paid science advisor to Cassava Sciences.

AUSTIN, Texas, May 10, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial results for first quarter ended March 31, 2024. Net income was $25.0 million compared to a net loss of $24.3 million for the same period in 2023. Net cash used in operations was $19.1 million during the first quarter of 2024. Cash use for operations for the first half of 2024 is still expected to be $35 to $45 million, driven primarily by expenses for our clinical program in Alzheimer’s disease.

Gross Proceeds from Warrants Represents the Sale of Approximately 5.7 Million Shares Of Common Stock At $22.00 Per Share

AUSTIN, Texas, May 01, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQSAVA) (“Cassava Sciences” or the "Company") has been advised by NASDAQ that end-of-day (“EOD”) tomorrow May 2, 2024, will be the last and final trading day for SAVAW warrants on NASDAQ. After EOD May 2, the Company expects NASDAQ to no longer accept or execute any trade for SAVAW warrants.

AUSTIN, Texas, April 15, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) (“Cassava Sciences” or the "Company") today announced that Monday, May 6, 2024 is the last and final day to exercise the warrants that were previously distributed to its shareholders on January 3, 2024 (the “Warrants”). Holders who exercise their Warrants will receive 1.5 shares of Cassava Sciences’ common stock per Warrant, for an effective price of approximately $22.00 per share.

AUSTIN, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the completion of another interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer’s disease. A routine, scheduled meeting of a Data and Safety Monitoring Board (DSMB) recommended that both of Cassava Sciences’ on-going Phase 3 studies continue as planned, without modification.

AUSTIN, Texas, March 04, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced plans to present a virtual oral presentation at the International Conference on Alzheimer’s and Parkison’s Disease (AD/PD 2024) taking place in Lisbon, Portugal from March 5-9, 2024.

AUSTIN, Texas, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial and operating results for the full year ended December 31, 2023 and presented corporate updates.

AUSTIN, Texas, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today reported top-line results of a two-year clinical safety study of simufilam, an investigational oral drug for the proposed treatment of Alzheimer’s disease dementia. The study enrolled over 200 patients with mild to moderate Alzheimer’s and consisted of two open-label treatment phases and a randomized, placebo-controlled withdrawal phase. Average changes in ADAS-Cog scores, baseline to month 24, indicate the following:

AUSTIN, Texas, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) ("Cassava Sciences" or the "Company") today announced the completion of a previously announced distribution of warrants (the “Warrants”) to its shareholders. The Warrants now trade on Nasdaq under the ticker SAVAW.

AUSTIN, Texas, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) ("Cassava Sciences" or the "Company") today announced a pro rata dividend distribution of warrants to holders of the Company's common stock as of December 22, 2023 (the “Record Date”). Shareholders will receive 4 warrants for each 10 shares of common stock held as of the Record Date, subject to rounding. Cassava Sciences will distribute the warrants to shareholders on or about January 3, 2024 (the “Distribution Date”). After the Distribution Date, the warrants are expected to list and trade on Nasdaq, separate from Cassava Sciences’ common stock, under the ticker SAVAW.

Dr. Nicaise, Mr. Gravier and Mr. Anderson have years of experience in drug development, healthcare M&A and working with the U.S. Government

 

AUSTIN, Texas, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today announced the completion of patient enrollment in a pair of Phase 3 trials to evaluate the safety and efficacy of oral simufilam versus placebo in Alzheimer's disease dementia.

AUSTIN, Texas, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced a potentially significant safety finding based on interim magnetic resonance imaging (MRI) brain data from Alzheimer’s patients who are enrolled in a Phase 3 clinical trial of simufilam. The MRI data suggest simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities, or ARIA. MRIs were all analyzed for ARIA by board-certified neuroradiologists.

AUSTIN, Texas, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today issued the following statement regarding an internal report purportedly prepared by City University of New York (CUNY). This report was leaked to the press. The leak of the CUNY report was preceded by a 40% increase in short selling activity in the stock of Cassava Sciences.

CEO to Present on Wednesday, October 11th, at 10:30am ET

AUSTIN, Texas, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today announced the completion of patient enrollment in a pivotal Phase 3 clinical trial. Eight hundred four (804) Alzheimer’s patients are enrolled in this 12-month trial. A second Phase 3 clinical trial with a target enrollment of approximately 1,100 patients is expected to complete patient enrollment in Q4 2023. Both on-going Phase 3 clinical trials are evaluating the safety and efficacy of oral simufilam in patients with Alzheimer's disease dementia.

AUSTIN, Texas, Sept. 18, 2023 (GLOBE NEWSWIRE) --  Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced a positive interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer’s disease. A routine, scheduled meeting of a Data and Safety Monitoring Board (DSMB) recommended that both of Cassava Sciences’ Phase 3 studies of simufilam continue as planned, without modification.

AUSTIN, Texas, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the publication of new research that confirms the biological activity of simufilam. Simufilam is Cassava Sciences’ novel drug candidate for people with Alzheimer’s disease dementia and is currently under evaluation in a pair of global Phase 3 clinical trials.

AUSTIN, Texas, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company committed to the treatment of Alzheimer’s disease dementia, today announced that it has been invited to present at the following investor conferences.

AUSTIN, Texas, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the second quarter ended June 30, 2023. Net loss was $26.4 million, or $0.63 per share, compared to a net loss of $19.3 million, or $0.48 per share, for the same period in 2022. Net cash used in operations was $33.2 million during the first half of 2023. Net cash use in second half 2023 is expected to be $40 to $50 million, driven primarily by expenses for our clinical program in Alzheimer’s disease.

AUSTIN, Texas, July 05, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today announced top-line clinical results from its Cognition Maintenance Study (CMS). The CMS is a small proof-of-concept study designed to demonstrate the effects of drug versus placebo in a randomized withdrawal trial design. The study enrolled 157 patients with mild-to-moderate Alzheimer’s disease, a more advanced and difficult-to-treat stage of disease.

AUSTIN, Texas, June 27, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced the publication of a new paper in Frontiers in Aging, a peer-reviewed journal focused on age-related scientific research. The new paper examined the effects of simufilam on mTOR. Simufilam is Cassava Sciences’ novel, oral drug candidate currently in Phase 3 clinical testing in patients with mild-to-moderate Alzheimer's disease dementia.

AUSTIN, Texas, June 12, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced a new science publication in Drug Development Research, a peer-reviewed journal. This article reviews certain receptor-protein interactions, including an overview of basic science supporting simufilam. Simufilam is Cassava Sciences’ oral investigational drug candidate that is currently in Phase 3 clinical trials in patients with mild-to-moderate Alzheimer's disease dementia.

AUSTIN, Texas, June 01, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced that its management has been invited to present at the Jefferies Global Healthcare Conference in New York City.

AUSTIN, Texas, May 11, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced the completion of patient dosing in a 6-month, randomized controlled trial of simufilam in over 125 patients with Alzheimer’s disease. This trial is known as the Cognition Maintenance Study (CMS). Simufilam is Cassava Sciences’ investigational oral drug treatment for Alzheimer’s disease dementia.

AUSTIN, Texas, May 08, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced new data from European researchers that highlight the bioactivity of simufilam on the filamin A (FLNA) protein. Prior research has shown that FLNA is altered in pituitary tumor cells, leading to impaired cell signaling. New in vitro data now show that simufilam can reverse this FLNA alteration in pituitary tumor cells, leading to improved cell signaling. The data also suggest that improved cell signaling may enhance the clinical efficacy of an FDA-approved drug used to manage a type of pituitary tumor.

AUSTIN, Texas, May 01, 2023 (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, 2023. Net loss was $24.3 million, or $0.58 per share, compared to a net loss of $17.5 million, or $0.44 per share, for the same period in 2022. Net cash used in operations was $13.3 million during the first quarter of 2023. New guidance for net cash use in first half 2023 is expected to be $30 to $40 million, which is revised downward from our previous guidance of $45 to $50 million, due primarily to the timing of certain clinical payment obligations.

AUSTIN, Texas, April 26, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced that Remi Barbier, President & Chief Executive Officer, has been invited to present at the 2023 H.C. Wainwright BioConnect Investor Conference in New York. In addition, management will be available for one-on-one meetings with institutional investors who are registered to attend this conference.

AUSTIN, Texas, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced financial results for the year ended December 31, 2022, and provided operating updates. Simufilam is Cassava Sciences’ oral drug candidate for the proposed treatment of Alzheimer’s disease dementia.

AUSTIN, Texas, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced an update on patient enrollment for its on-going Phase 3 clinical studies of simufilam for the treatment of Alzheimer’s disease dementia. Simufilam, an oral drug, is Cassava Sciences’ proprietary lead drug candidate.

AUSTIN, Texas, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today announced positive top-line Phase 2 results for simufilam, its oral drug candidate for Alzheimer’s disease dementia. This was an open-label safety study with exploratory efficacy endpoints. The study enrolled over 200 patients with mild-to-moderate Alzheimer’s disease (MMSE 16-26). Study participants were administered open-label simufilam tablets 100mg twice daily for 1 year or more. Endpoints were measured at baseline (study entry) and month 12.

AUSTIN, Texas, Dec. 20, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) announced today that a valued and long-time member of the Company, Nadav Friedmann, PhD, MD, has died following a brief journey with cancer, only recently discovered.

AUSTIN, Texas, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced the completion of drug administration in an open-label study of simufilam for Alzheimer’s disease. This study was designed to evaluate long-term drug safety and to measure cognitive changes (ADAS-cog) over 12 months in approximately 200 patients with mild-to-moderate Alzheimer’s disease treated with open-label simufilam 100 mg twice daily. Simufilam is Cassava Sciences’ oral drug candidate for Alzheimer’s disease dementia.

AUSTIN, Texas, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) (the “Company” or “Cassava Sciences”), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced the closing of its previously announced registered direct offering of 1,666,667 shares of its common stock, at a purchase price per share of $30, for gross proceeds of approximately $50 million.

AUSTIN, Texas, Nov. 18, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) (the “Company” or “Cassava Sciences”), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced that it has entered into a definitive agreement with several healthcare-focused and other institutional investors for the purchase of 1,666,667 shares of its common stock, at a purchase price of $30 per share, for gross proceeds of approximately $50 million, in a registered direct offering. The closing of the offering is expected to occur on or about November 22, 2022, subject to the satisfaction of customary closing conditions.

– $174.7 Million Cash and Cash Equivalents at September 30, 2022 –

AUSTIN, Texas, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced that it has filed a lawsuit in federal court against certain individuals who executed a “short and distort” campaign against the Company. The 150+ page complaint alleges that the Defendants’ disinformation campaign caused a precipitous decline in Cassava Sciences’ stock price, a multi-billion dollar decline in its market capitalization, and delayed the Company’s work in developing a treatment for Alzheimer’s disease.

AUSTIN, Texas, Oct. 27, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, announced the expansion of its leadership team with the appointment of Christopher Cook as Senior Vice President and General Counsel. This is a newly created position, reporting to Remi Barbier, President & CEO.  

AUSTIN, Texas, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced the initiation of an open-label extension study. This study is designed to provide no-cost access to simufilam, an investigational drug, to patients with Alzheimer’s disease who complete either one of Cassava Sciences’ on-going Phase 3 studies, which are double-blind, placebo-controlled trials.

- In November 2021, Cassava Sciences previously disclosed that certain government agencies had asked for corporate information and at that time, the media widely reported on these prior disclosures.