Cassava Sciences Reports Second Quarter Financial Results for 2022, Mid-year Corporate Update and Interim Analysis of Open-label Study
- Phase 3 Program - Over 400 Patients Are Now Enrolled in Our Phase 3 Clinical Studies.
- Open-label Study – Results of an Interim Analysis on the First 100 Patients Who Have Completed at Least 12 Months of Open-label Treatment with Simufilam Follow:
- Drug Appears Safe and Well Tolerated.
- Overall ADAS-Cog11 Scores Improved an Average of 1.5 Points (S.D. ± 6.6; P<0.05)
- 63% of the 100 Patients Showed an Improvement in ADAS-Cog11 Scores, and
This Group of Patients Improvedan Average of 5.6 Points (S.D. ± 3.8).
- An Additional 21% of the 100 Patients Declined Less Than 5 Points on ADAS-Cog11, and
This Group of Patients Declinedan Average of 2.7 Points (S.D. ± 1.4).
- Cognition Maintenance Study - Completion of Patient Enrollment is Expected Q4 2022.
- Financial Results - Net Loss for Q2 2022 Was
$19.3 Million, or $0.48Per Share.
- Cash Position -
$197.2 Millionof Cash and Cash Equivalents at June 30, 2022.
“I’m pleased with our operating performance in the first half of 2022,” said
Update on Patient Enrollment for Phase 3 Program
A total of over 400 patients are now enrolled in our on-going Phase 3 program of simufilam in Alzheimer’s disease. Enrollment is almost evenly split between the two Phase 3 studies.
Overview of Phase 3 Program with Simufilam in Alzheimer's Disease
Our Phase 3 program consists of two double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease. Both Phase 3 studies have Special Protocol Assessments (SPA) from the
RETHINK-ALZ is the trade name of our 52-week Phase 3 study. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety & efficacy of oral simufilam 100 mg or placebo, twice daily, over 52 weeks in approximately 750 patients with Alzheimer’s disease.
REFOCUS-ALZ is the trade name of our 76-week Phase 3 study. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety & efficacy of oral simufilam 100 mg, 50 mg or placebo, twice daily, over 76 weeks in approximately 1,000 patients with Alzheimer’s.
Future Open-label Extension Study for the Phase 3 Program
In the second half of 2022, we expect to initiate an open-label extension study for our Phase 3 program. This new study is designed to provide no-cost access to simufilam to patients with Alzheimer’s disease who have successfully completed a Phase 3 study of simufilam.
On-going Open-label Study with Simufilam in Alzheimer's Disease
On-going Open-label Study - Interim Analysis on 100 Subjects at 12 Months
An interim analysis was conducted on the first 100 evaluable patients who completed at least 12 months of open-label treatment with simufilam 100 mg twice daily. Top-line results of this interim analysis show that from baseline to month-12:
- Drug appears safe and well tolerated.
- Overall ADAS-Cog11 scores improved an average of 1.5 points (S.D. ± 6.6; P<0.05)
- 63% of the 100 patients showed an improvement in ADAS-Cog11 scores, and this group of patients improved an average of 5.6 points (S.D. ± 3.8).
- An additional 21% of the 100 patients declined less than 5 points on ADAS-Cog11, and this group of patients declined an average of 2.7 points (S.D. ± 1.4).
The 11-item Alzheimer’s Disease Assessment Scale–Cognitive subscale (ADAS-Cog) was originally developed by the research community to measure cognitive impairment in patients with Alzheimer’s disease. ADAS-Cog is often used in clinical studies of patients with Alzheimer’s because it can help determine incremental improvements or declines in cognition over time.
Standard deviation (“S.D.”) is a measure of how dispersed the data is in relation to the average. A low standard deviation generally shows the data are closely clustered around the average. A high standard deviation generally shows that the data is widely spread.
All clinical data from our open-label study are inherently exploratory in nature and, as with all open-label data, should be interpreted with caution. Data results from our open-label study does not constitute, and should not be interpreted as, evidence of therapeutic benefit for simufilam.
Cognition Maintenance Study (CMS) with Simufilam in Alzheimer's Disease
The target enrollment for the CMS is 100 or more patients. Over 50 patients have now completed this study. Our goal is to complete patient enrollment for the CMS in Q4 2022. We expect to announce clinical results of the CMS approximately third-quarter 2023.
Our investigational product candidate, called SavaDx, is an early-stage program focused on detecting the presence of Alzheimer’s disease from a simple blood draw. SavaDx is currently designed as an antibody-based detection system for altered filamin A (FLNA) protein. Working with third parties, we continue to evaluate an innovative method to detect FLNA without the use of antibodies. For business, technical and personnel reasons, we continue to prioritize the development of simufilam, our novel drug candidate, over SavaDx.
Net loss for the second quarter 2022 was
Financial Results for Second Quarter 2022
June 30, 2022, cash and cash equivalents were $197.2 million, with no debt.
- Net loss was
$19.3 million, or $0.48per share. This compares to a net loss of $5.1 million, or $0.13per 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
$34.6 millionduring the first six months of 2022.
- Net cash use in operations for full year 2022 is expected to be approximately
$80to $90 million.
- Research and development (R&D) expenses were
$16.9 million. This compared to $3.9 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 and personnel expenses.
- General and administrative (G&A) expenses were
$3.0 million. This compared to $1.2 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.
Simufilam (sim-uh-FILL-am) is a 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 Contact:
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 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 this study, or any other study. 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
||Six months ended
|Research and development, net of grant reimbursement||$||16,948||$||3,901||$||31,854||$||6,430|
|General and administrative||2,969||1,237||5,884||2,241|
|Total operating expenses||19,917||5,138||37,738||8,671|
|Other income, net||275||—||538||—|
|Net loss per share, basic and diluted||$||(0.48||)||$||(0.13||)||$||(0.92||)||$||(0.22||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||40,015||39,953||39,989||38,843|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||197,232||$||233,437|
|Prepaid expenses and other current assets||6,969||11,045|
|Total current assets||204,201||244,482|
|Property and equipment, net||22,155||20,616|
|Operating lease right-of-use assets||166||210|
|Intangible assets, net||859||1,075|
|Liabilities and stockholders' equity|
|Accrued development expense||3,318||2,803|
|Accrued compensation and benefits||176||1,877|
|Operating lease liabilities, current||100||97|
|Other accrued liabilities||370||631|
|Total current liabilities||8,722||12,534|
|Operating lease liabilities, non-current||88||139|
|Other non- current liabilities||201||194|
|Common Stock and additional paid-in-capital||462,531||461,221|
|Total stockholders' equity||218,370||253,915|
|Total liabilities and stockholders' equity||$||227,381||$||266,782|
Source: Cassava Sciences, Inc.