Cassava Sciences Reports Third Quarter 2023 Financial and Operating Results
- Enrollment completed for Phase 3 trials evaluating oral simufilam in Alzheimer's.
- Over 1,900 patients randomized in on-going Phase 3 trials.
- Top-line results for 52-week Phase 3 trial expected approximately year-end 2024; top-line results for 76-week Phase 3 trial expected approximately mid-year 2025.
- MRI safety data suggests simufilam is not associated with ARIA.
$142.4 Millionin cash and cash equivalents at September 30, 2023.
“In the third quarter,
Simufilam is Cassava Sciences’ proprietary oral drug candidate. This investigational drug binds to altered filamin A protein in the brain and restores its normal shape and function. By targeting altered filamin A, simufilam may help patients with Alzheimer’s achieve better health outcomes.
The first Phase 3 trial (NCT04994483) has a 52-week treatment period; 804 Alzheimer’s patients were randomized into this study. Top-line results for the 52-week Phase 3 study are currently expected approximately year-end 2024.
The second Phase 3 trial (NCT05026177) has a 76-week treatment period; 1,125 Alzheimer’s patients were randomized into this study. Top-line results for the 76-week Phase 3 study are currently expected approximately mid-year 2025.
Financial Results for Third Quarter 2023
September 30, 2023, cash and cash equivalents were $142.4 million, with no debt.
- Net loss was
$25.7 million, or $0.61per share. This compares to a net loss of $20.3 million, or $0.51per share, for the same period in 2022. Net loss increased due primarily to increases in patient enrollment and associated costs to conduct the Phase 3 clinical program, as well as other studies with simufilam.
- Net cash used in operations was
$59.7 millionduring the first nine months of 2023.
- Net cash use in operations for second half 2023 is expected to be
$40to $50 million, consistent with previous guidance and driven primarily by expenses for our clinical program in Alzheimer’s disease.
- Research and development (R&D) expenses were
$23.6 million. This compared to $18.5 millionfor the same period in 2022. R&D expenses increased due primarily to increasing patient enrollment and costs to conduct the Phase 3 clinical program, as well as other studies with simufilam.
- General and administrative (G&A) expenses were
$4.3 million. This compared to $2.8 millionfor the same period in 2022. G&A expenses increased due to activities and expenses related to legal services as well as increases in stock-based compensation.
For more information, please visit: https://www.CassavaSciences.com
For More Information Contact:
(512) 501-2450 or ESchoen@CassavaSciences.com
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, that may include but are not limited to: the design, scope, conduct, continuation, completion, intended purpose, or future results of our on-going Phase 3 program of simufilam in patients with Alzheimer's disease; the suitability of clinical data from our Phase 3 program to support the filing of an NDA; any findings or recommendations by the DSMB relating to the interim safety of simufilam in our on-going Phase 3 clinical trials; interim MRI safety data for the Phase 3 program, including ARIA; the risk of current or future findings of treatment-emergent ARIA in our clinical program of simufilam; any expected clinical results of Phase 3 studies; the treatment of people with Alzheimer’s disease dementia; the safety or efficacy of simufilam in people with Alzheimer’s disease dementia; expected cash use in future periods; comments made by our employees regarding simufilam, drug effect, and the treatment of Alzheimer’s disease; 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.
Simufilam is our investigational product candidate. It is not approved by any regulatory authority in any jurisdiction and its safety, efficacy or other desirable attributes have not been established in patients.
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. Clinical results and analyses of our previous studies should not be relied upon as predictive of Phase 3 studies 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, any unanticipated impacts of inflation 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||$||23,603||$||18,526||$||70,692||$||50,380|
|General and administrative||4,276||2,819||12,476||8,703|
|Total operating expenses||27,879||21,345||83,168||59,083|
|Other income, net||223||210||616||748|
|Net loss per share, basic and diluted||$||(0.61||)||$||(0.51||)||$||(1.82||)||$||(1.43||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||42,002||40,050||41,845||40,009|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||142,350||$||201,015|
|Prepaid expenses and other current assets||7,834||10,211|
|Total current assets||150,184||211,226|
|Property and equipment, net||22,077||22,864|
|Operating lease right-of-use assets||—||122|
|Intangible assets, net||268||622|
|Liabilities and stockholders' equity|
|Accrued development expense||7,344||2,280|
|Accrued compensation and benefits||187||170|
|Operating lease liabilities, current||—||104|
|Other accrued liabilities||391||492|
|Total current liabilities||17,414||7,063|
|Operating lease liabilities, non-current||—||35|
|Other non- current liabilities||—||197|
|Common Stock and additional paid-in-capital||514,965||511,091|
|Total stockholders' equity||155,115||227,539|
|Total liabilities and stockholders' equity||$||172,529||$||234,834|
Source: Cassava Sciences, Inc.