Cassava Sciences Reports First Quarter 2021 Financial Results and Announces Guidance on Clinical Data Release
- 9 Month Interim Analysis of Open-label Study to be Presented at a
- Initiation of Pivotal Phase 3 Program Remains On-track for 2nd Half 2021 -
- Initiation of Cognition Maintenance Study On-track for
- Cash and cash equivalents were
“Alzheimer’s is a progressive disease, so a patient’s cognition is expected to worsen over time,” said
About the Open-label Study with Simufilam
The study’s target enrollment is approximately 150 subjects with mild-to-moderate Alzheimer’s disease (recently increased by 50 subjects). One-hundred subjects have enrolled in this study across multiple clinical sites in the
About the Cognition Maintenance Study (CMS)
About the Phase 3 Clinical Program
Cassava Sciences’ first Phase 3 study is designed to evaluate disease-modifying effects of simufilam in Alzheimer’s 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’s disease.
Cassava Sciences’ second Phase 3 study is designed to evaluate symptomatic improvement in Alzheimer’s 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.
Cassava Sciences’ latest corporate presentation is available on its website under the Investors/Presentations page: https://www.CassavaSciences.com
Financial Results for First Quarter 2021
Net loss was
Net cash use for operations for full-year 2021 is expected to be approximately
Financial Highlights for First Quarter 2021
March 31, 2021, cash and cash equivalents were $282.2 million, compared to $93.5 millionat December 31, 2020, with no debt. Cash balance included net proceeds of approximately $189.8 millionfrom the sale of 4.1 million shares of common stock completed February 2021. Cash balance also included $0.7 millionfrom exercise of common stock warrants in the quarter. There were no remaining common stock warrants outstanding as of March 31, 2021.
- Net cash used in operations during the quarter ended
March 31, 2021was $2.3 million, net of reimbursements received from NIHgrant awards.
- Research grant funding reimbursements of
$0.6 millionwere received from NIHand recorded as a reduction in research and development (R&D) expenses. This compared to $1.3 millionof NIHgrant receipts received for the same period in 2020.
- Net cash use for operations for full year 2021 is expected to be approximately
$20to $25 million, consistent with previous financial guidance. 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.
- R&D expenses were
$2.5 million. This compared to $0.5 millionfor the same period in 2020, representing a 365% increase. This increase was due primarily to costs related to manufacture of clinical trial supplies in anticipation of launching a Phase 3 clinical program in simufilam, increased personnel expenses, as well as a decrease in grant funding received from NIHcompared to the prior year.
- General and administrative (G&A) expenses were
$1.0 million. This compared to $0.8 millionfor the same period in 2020, representing a 29% increase. This increase was due primarily to higher insurance costs and professional fees compared to the prior year.
Simufilam is a proprietary, small molecule (oral) drug 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
Simufilam and SavaDx were both developed in-house. Both product candidates are substantially funded by peer-review research grant awards from the
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
Cassava Sciences’ mission is to discover and develop innovations for chronic, neurodegenerative conditions. Over the past 10 years,
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Cautionary Note Regarding Forward-Looking Statements: This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: our strategy and plans; expected cash use in future periods; the treatment of Alzheimer’s disease; the status of current and future clinical studies with simufilam, including the interpretation of an interim analysis of an open-label study; plans to conduct additional interim analyses of an open-label study and the timing thereof; planned enrollment targets to said open-label program; our intention to initiate a Phase 3 clinical program with simufilam and the timing, enrollment, duration and other details thereof; verbal commentaries made by our employees; and potential benefits, if any, of our product candidates. These statements may be identified by words such as “may,” “anticipate,” “believe,” “could,” “expect,” “would”, “forecast,” “intend,” “plan,” “possible,” “potential,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Our clinical results from earlier-stage clinical trials may not be indicative of full results or results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.
Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, the severity and duration of health care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic on our business operations, and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended
The content of this press release is solely our responsibility and does not necessarily represent the official views of the
– Financial Tables Follow –
|CONDENSED STATEMENTS OF OPERATIONS|
|(unaudited, in thousands, except per share amounts)|
|Three months ended
|Research and development, net of grant reimbursement||$||2,529||$||544|
|General and administrative||1,004||778|
|Gain on sale of property and equipment||—||(100||)|
|Total operating expenses||3,533||1,222|
|Net loss per share, basic and diluted||$||(0.09||)||$||(0.05||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||37,721||24,481|
|CONDENSED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||282,192||$||93,506|
|Other current assets||1,574||488|
|Total current assets||283,766||93,994|
|Property and equipment, net||10||11|
|Operating lease right-of-use assets||274||295|
|Liabilities and stockholders' equity|
|Accrued development expense||1,553||719|
|Accrued compensation and benefits||99||83|
|Operating lease liabilities, current||84||58|
|Other accrued liabilities||50||94|
|Total current liabilities||2,650||1,865|
|Operating lease liabilities, non-current||213||235|
|Common Stock and additional paid-in-capital||459,634||267,121|
|Total stockholders' equity||281,187||92,200|
|Total liabilities and stockholders' equity||$||284,050||$||94,300|
Source: Cassava Sciences, Inc.