Cassava Sciences Announces Full-year 2020 Financial Results and Business Highlights
“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
“We have approximately
Summary of Expected Milestones for 2021
||Completed Q1 2021|
||Completed Q1 2021|
||Completed Q1 2021|
||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
December 31, 2020, cash and cash equivalents were $93.5 million, compared to $23.1 millionat December 31, 2019, with no debt. 2020 year-end cash balance includes net proceeds of $70.3 millionfrom the sale of 9.4 million shares of common stock in a follow-on public offering completed November 2020and proceeds of $4.9 millionfrom 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, 2020was $5.4 million, net of reimbursements received from NIHgrant 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, 2020were $3.1 millioncompared to $1.6 millionfor 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 NIHreimbursement compared to the prior year. Cassava Sciencesreceived reimbursements of $4.2 million in 2020 from research grant awards from NIHthat 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, 2020were $3.7 millioncompared to $3.4 millionfor the same period in 2019, or a 10% increase. The increase was due primarily to higher insurance expenses compared to the prior year.
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
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
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; planned milestones for 2021; 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 a second interim analysis of an open-label study and the timing thereof; planned enrollment and other changes 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,” “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
– Financial Tables Follow –
|CONDENSED STATEMENTS OF OPERATIONS|
|(unaudited, in thousands, except per share amounts)|
|Three months ended
|Research and development, net of grant reimbursement||$||1,519||$||738||$||3,053||$||1,568|
|General and administrative||1,105||838||3,739||3,391|
|Gain on sale of property and equipment||—||—||(346||)||—|
|Total operating expenses||2,624||1,576||6,446||4,959|
|Net loss per share, basic and diluted||$||(0.09||)||$||(0.08||)||$||(0.24||)||$||(0.27||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||30,157||18,153||26,105||17,412|
|CONDENSED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||93,506||$||23,081|
|Other current assets||488||268|
|Total current assets||93,994||23,349|
|Property and equipment, net||11||47|
|Operating lease right-of-use assets||295||90|
|Liabilities and stockholders' equity|
|Accrued development expense||719||777|
|Accrued compensation and benefits||83||58|
|Operating lease liabilities, current||58||90|
|Other accrued liabilities||94||9|
|Total current liabilities||1,865||1,387|
|Operating lease liabilities, non-current||235||—|
|Common stock and additional paid-in-capital||267,121||190,686|
|Total stockholders' equity||92,200||22,099|
|Total liabilities and stockholders' equity||$||94,300||$||23,486|
Source: Cassava Sciences, Inc.