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Cassava Sciences, now Filana Therapeutics, reports developments around its biotechnology program for central nervous system disorders, with current focus on Tuberous Sclerosis Complex (TSC)-related epilepsy. Company updates center on simufilam, a proprietary investigational oral small molecule intended to modulate filamin A protein, including preclinical work, clinical-development planning, and publication of prior Phase 3 Alzheimer’s disease trial results.
Recurring news also covers financial results, cash-use updates, leadership and board changes, and legal or regulatory matters, including the closure of government inquiries and securities litigation updates. The completed name change and ticker transition are part of the company’s durable corporate-status history.
Cassava Sciences, focused on Alzheimer’s disease, reported a net loss of $1.1 million, or $0.05 per share, for Q2 2020, unchanged from the prior year's loss. Cash and cash equivalents stood at $25.3 million as of June 30, 2020. The company continues to expect a total net cash use of approximately $5.0 million for the year. Additionally, the Phase 2b study of PTI-125 is set to announce final results in September 2020, following an initial bioanalysis showing unexplained variability. The open-label study of PTI-125 has surpassed 50% enrollment. SavaDx demonstrated target engagement in preliminary studies.
Cassava Sciences (Nasdaq: SAVA) announced that its lead neuroscientist, Dr. Lindsay H. Burns, will present on SavaDx at the Biomarkers for Alzheimer’s Disease Summit on July 15, 2020. SavaDx aims to detect Alzheimer’s through a simple blood test, potentially years before symptoms appear, and is backed by NIH funding. Cassava's lead therapeutic candidate, PTI-125, aims to treat Alzheimer’s by restoring altered brain protein function. This follows a Phase 2b study completion in early 2020, with results expected by Q3 2020.
Cassava Sciences (Nasdaq:SAVA) announced its addition to the Russell 2000 and Russell 3000 Indexes, effective June 26, 2020. This decision is expected to enhance market visibility for the company, which is focused on Alzheimer’s disease. The company is preparing to release comprehensive results from its Phase 2b study of PTI-125 by Q3 2020. This study, which included 64 patients, received substantial funding from the National Institutes of Health. PTI-125 aims to address Alzheimer’s pathology, and ongoing trials show strong interest from patients and physicians.
Cassava Sciences, a clinical-stage biotechnology company, announced insights from its ongoing Phase 2b study of PTI-125 for Alzheimer’s disease. High variability in biomarker levels in the control arm suggests a need for reassessment of overall results. The company plans to re-analyze cerebrospinal fluid and lymphocyte samples to gather further evidence for the drug's efficacy and cognition effects. Results from these analyses are anticipated in the latter half of 2020 and will guide future drug development strategies.
Cassava Sciences, Inc. (Nasdaq: SAVA) released results from its Phase 2b study of PTI-125 for Alzheimer's disease, which did not meet its primary endpoint related to CSF tau protein levels. However, a secondary analysis indicated a significant reduction in CSF IL1-beta levels (p0.035). Notably, high variability in CSF biomarker levels was observed, complicating the interpretation of results. While the drug was deemed safe and well-tolerated, the company plans further analysis to understand the study outcomes better.
Cassava Sciences (SAVA) announced financial results for Q1 2020, reporting a net loss of $1.2 million ($0.05 per share), an improvement from last year's $1.4 million loss. Cash reserves stand at $25.6 million with no debt, and cash use for the year is projected at $5 million. The company has received $2.9 million in NIH research grants for PTI-125, a drug candidate for Alzheimer's, with early data from a Phase 2b study expected soon. An open-label study has also begun, with 20% enrollment. Overall, operations remain stable amidst the pandemic.