On March 23, 2021 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the year ended December 31, 2020 and provided business updates. Unaudited cash and cash equivalents were approximately $280 million as of February 2021 (Press release, Pain Therapeutics, MAR 23, 2021, View Source [SID1234577039]).
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"In Q1 2021 we announced that our lead drug candidate, simufilam, improved cognition scores in 50 patients with Alzheimer’s disease who completed at least 6 months of open-label treatment," said Remi Barbier, President & CEO. "In mid-2021, we look forward to announcing cognition scores in patients who’ll have completed at least 12 months of open-label treatment with simufilam. To our knowledge, no drug has stabilized, much less improved, cognition scores over 12 months in patients with Alzheimer’s disease. For this reason, I feel there is a sense of anticipation around the upcoming release of 12-month clinical data from our open-label study, as well as our plans to conduct a pivotal Phase 3 program with simufilam in the second half of 2021. With solid science, the right people in place, cash in the bank and a clinical roadmap that makes sense, I think Cassava Sciences is positioned to becoming a premier organization to serve patients with Alzheimer’s disease."
"We have approximately $280 million in cash on our balance sheet, against expected cash use of approximately $20 to $25 million in 2021," said Eric Schoen, Chief Financial Officer. "We believe our cash levels support a pivotal Phase 3 clinical program of simufilam in Alzheimer’s disease."
Cassava Sciences remains on-track to initiate two pivotal Phase 3 studies in second half of 2021. In mid-year 2021, the Company also plans to initiate a randomized, placebo-controlled cognition maintenance study in patients with mild-to-moderate Alzheimer’s disease. Expected milestones for 2021 appear below.
Summary of Expected Milestones for 2021
Milestone Anticipated Timing
End-of-phase 2 (EOP2) meeting with FDA to gain general agreement around a Phase 3 clinical development program in Alzheimer’s disease dementia.
Completed Q1 2021
Announce cognition scores from a pre-planned interim analysis (6-month data) of an ongoing, open-label study of simufilam in Alzheimer’s disease.
Completed Q1 2021
Announce results of EOP2 meeting with FDA.
Completed Q1 2021
Announce long-term, large-scale drug supply agreement for simufilam with contract manufacturer (Evonik).
Completed Q1 2021
Announce cognition scores of a pre-planned interim analysis (12-month data) of an ongoing, open-label study of simufilam in Alzheimer’s disease. Mid-2021
Initiation of a Cognition Maintenance Study (CMS) with simufilam – randomized, placebo-controlled design in Alzheimer’s patients. Mid-2021
Manufacture large-scale Phase 3 clinical trial supplies. Ongoing, rolling basis
Initiation of a first Phase 3 study of simufilam — 18-month, approx. 1,000+ patients with Alzheimer’s disease. Q3 2021
Initiation of a second Phase 3 study of simufilam — 12-month, approx. 600+ patients with Alzheimer’s disease. Q4 2021
Complete patient enrollment of an on-going, open-label study of simufilam in Alzheimer’s patients. Ongoing, rolling basis
Publication of Phase 2b results in peer-reviewed journal. 2021
Initiate validation study with SavaDx – blood-based diagnostic to detect Alzheimer’s disease. 2021
Net cash use in 2021 is expected to be driven by higher headcount and personnel expenses, manufacturing costs around large-scale drug supply, professional services expenses related to clinical programs, and operating costs such as insurance, office space and IT related expenses.
Full Year 2020 Financial Results: Net loss in full-year 2020 was $6.3 million, or $0.24 per share, compared to a net loss in 2019 of $4.6 million, or $0.27 per share. Net cash used in operations in full-year 2020 was $5.4 million. Cash and cash equivalents were $93.5 million as of December 31, 2020. Unaudited cash and cash equivalents were approximately $280 million as of February 2021, including net proceeds of approximately $189.7 million from the sale of 4.1 million shares of common stock completed February 12, 2021.
Financial Highlights
At December 31, 2020, cash and cash equivalents were $93.5 million, compared to $23.1 million at December 31, 2019, with no debt. 2020 year-end cash balance includes net proceeds of $70.3 million from the sale of 9.4 million shares of common stock in a follow-on public offering completed November 2020 and proceeds of $4.9 million from the exercise of 4.0 million common stock warrants during 2020. In 2021, all remaining warrants outstanding were exercised, resulting in additional proceeds of $0.7 million.
Net cash used in operations during the year ended December 31, 2020 was $5.4 million, net of reimbursements received from NIH grant awards.
Net cash use for full year 2021 is expected to be approximately $20 – $25 million, depending on the rate of clinical site initiation and enrollment rates in upcoming clinical studies of simufilam.
Research and development expenses for the year ended December 31, 2020 were $3.1 million compared to $1.6 million for the same period in 2019, or a 95% increase. The increase was due primarily to costs related to the manufacture of Phase 3 clinical trial supplies in the fourth quarter of 2020 as well as lower NIH reimbursement compared to the prior year.
Cassava Sciences received reimbursements of $4.2 million in 2020 from research grant awards from NIH that are recorded as a reduction of research and development expense, compared to $4.7 million in 2019.
General and administrative expenses for the year ended December 31, 2020 were $3.7 million compared to $3.4 million for the same period in 2019, or a 10% increase. The increase was due primarily to higher insurance expenses compared to the prior year.
About Simufilam
Simufilam is a proprietary, small molecule (oral) drug candidate that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science for simufilam is published in peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation and Journal of Prevention of Alzheimer’s Disease. Cassava Sciences is also developing an investigational diagnostic, called SavaDx, to detect Alzheimer’s disease with a simple blood test.
Simufilam and SavaDx were both developed in-house. Both product candidates are substantially funded by peer-review research grant awards from the National Institutes of Health (NIH). Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. As of 2020, there were approximately 50 million people worldwide living with dementia, a figure expected to increase to 150 million by 2050.1 The annual global cost of dementia is now above $1 trillion, according to Alzheimer’s Disease International, a charitable organization.