Cassava Sciences Reports Third Quarter Financial Results for 2022 and Business Updates
– Over 650 Patients Now Enrolled in Phase 3 Program -
– New Clinical Data for Simufilam in Alzheimer’s Disease Expected –
“The clinical development of oral simufilam for Alzheimer’s disease continues to make headway,” said
Net loss for third quarter 2022 was
Financial Results for Third Quarter 2022
September 30, 2022, cash and cash equivalents were $174.7 million, with no debt.
- Net loss was
$20.3 million, or $0.51per share. This compares to a net loss of $9.6 million, or $0.24per share, for the same period in 2021. Net loss increased compared to the prior period due primarily to a significant increase in our R&D activities for a Phase 3 program of simufilam in Alzheimer’s disease.
- Net cash used in operations was
$56.2 millionduring the first nine months of 2022.
- Net cash use in operations for full year 2022 is expected to be approximately
$80to $90 million, consistent with previous guidance.
- Research and development (R&D) expenses were
$18.5 million. This compared to $8.0 millionfor the same period in 2021. R&D expenses increased compared to the prior period due primarily to increased activities and expenses related to clinical and pre-clinical studies and support functions.
- General and administrative (G&A) expenses were
$2.8 million. This compared to $1.7 millionfor the same period in 2021. G&A expenses increased compared to the prior period due primarily to increased activities and expenses related to legal services as well as depreciation and amortization.
Overview of On-going Phase 3 Clinical Program
Cassava Sciences’ Phase 3 program consists of two randomized controlled trials of oral simufilam in patients with mild-to-moderate Alzheimer’s disease. The two studies are named RETHINK-ALZ and REFOCUS-ALZ. In 2021, both studies received Special Protocol Assessments (SPA) from the
Over 650 patients are now enrolled in our Phase 3 studies. Studies are being conducted in over 100 clinical trial sites across the
Cassava Sciences’ RETHINK-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing functional decline over 52 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100 mg or matching placebo twice daily.
Cassava Sciences’ REFOCUS-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 76 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 1,000 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1:1) to simufilam 100 mg, 50 mg, or matching placebo twice daily.
Both of Cassava Sciences’ Phase 3 studies have the same co-primary efficacy endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a functional scale). A secondary efficacy endpoint is iADRS, a clinical tool that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL.
Open-label Study – closed enrollment
Cognition Maintenance Study (CMS) – on-going
SavaDx – on-going
This earlier-stage program refers to the detection of Alzheimer’s disease with a simple blood test. SavaDx was initially designed as an antibody-based detection system for altered filamin A (FLNA). We are currently evaluating a new approach—based on mass spectrometry—to detect FLNA in plasma without the use of antibodies. Mass spectrometry is an analytical tool that measures the mass-to-charge ratio (m/z) of a molecule present in a sample.
Simufilam (sim-uh-FILL-am) is Cassava Sciences’ proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA) protein in the brain.
For more information, please visit: https://www.CassavaSciences.com
For More Information Contact:
(512) 501-2450, or
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; the timing, enrollment, duration, geography and other details of a Phase 3 clinical program with simufilam; plans to release clinical results of our open-label study or CMS study, and the timing thereof; the development path for SavaDx and the use of mass spec as an alternative method of detection; 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 interim data and analysis should not be relied upon as predictive of full study results for any of our studies. 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 CONSOLIDATED STATEMENTS OF OPERATIONS|
|(unaudited, in thousands, except per share amounts)|
|Three months ended
||Nine months ended
|Research and development, net of grant reimbursement||$||18,526||$||8,041||$||50,380||$||14,471|
|General and administrative||2,819||1,712||8,703||3,953|
|Total operating expenses||21,345||9,753||59,083||18,424|
|Other income, net||210||176||748||176|
|Net loss per share, basic and diluted||$||(0.51||)||$||(0.24||)||$||(1.43||)||$||(0.46||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||40,050||39,957||40,009||39,218|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||174,662||$||233,437|
|Prepaid expenses and other current assets||8,610||11,045|
|Total current assets||183,272||244,482|
|Property and equipment, net||23,130||20,616|
|Operating lease right-of-use assets||144||210|
|Intangible assets, net||740||1,075|
|Liabilities and stockholders' equity|
|Accrued development expense||4,096||2,803|
|Accrued compensation and benefits||160||1,877|
|Operating lease liabilities, current||102||97|
|Other accrued liabilities||416||631|
|Total current liabilities||8,308||12,534|
|Operating lease liabilities, non-current||62||139|
|Other non- current liabilities||197||194|
|Common Stock and additional paid-in-capital||463,137||461,221|
|Total stockholders' equity||198,719||253,915|
|Total liabilities and stockholders' equity||$||207,286||$||266,782|
Source: Cassava Sciences, Inc.