Cassava Sciences Reports Q2 2023 Financial Results and Operating Updates
- Results of a randomized, controlled trial of oral simufilam in Alzheimer’s disease announced
- Over 1,587 patients now enrolled in Phase 3 studies of simufilam in Alzheimer’s disease, an increase of over 340 patients in the last three months.
- Completion of patient enrollment for Phase 3 program still expected Q4 2023.
$168.4 Millionin Cash and Cash Equivalents at June 30, 2023.
Financial Results for Second Quarter 2023
June 30, 2023, cash and cash equivalents were $168.4 million, with no debt.
- Net loss was
$26.4 million, or $0.63per share. This compares to a net loss of $19.3 million, or $0.48per share, for the same period in 2022. Net loss increased due primarily to increases in the rate of 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
$33.2 millionduring the first six months of 2023.
- Net cash use in operations for second half 2023 is expected to be
$40to $50 million, driven primarily by expenses for our clinical program in Alzheimer’s disease.
- Research and development (R&D) expenses were
$25.0 million. This compared to $16.9 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
$3.8 million. This compared to $3.0 millionfor the same period in 2022. G&A expenses increased due primarily to increases in stock-based compensation and activities and expenses related to legal services.
On-going Phase 3 Studies with Simufilam
Simufilam is Cassava Sciences’ proprietary, small molecule (oral) drug candidate 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 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 or intended purpose of our randomized withdrawal study, whose top-line results we announced in
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 open-label study 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
||Six months ended
|Research and development, net of grant reimbursement||$||24,969||$||16,948||$||47,089||$||31,854|
|General and administrative||3,808||2,969||8,200||5,884|
|Total operating expenses||28,777||19,917||55,289||37,738|
|Other income, net||203||275||393||538|
|Net loss per share, basic and diluted||$||(0.63||)||$||(0.48||)||$||(1.21||)||$||(0.92||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||41,793||40,015||41,766||39,989|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||168,438||$||201,015|
|Prepaid expenses and other current assets||6,095||10,211|
|Total current assets||174,533||211,226|
|Property and equipment, net||22,328||22,864|
|Operating lease right-of-use assets||—||122|
|Intangible assets, net||387||622|
|Liabilities and stockholders’ equity|
|Accrued development expense||7,044||2,280|
|Accrued compensation and benefits||220||170|
|Operating lease liabilities, current||—||104|
|Other accrued liabilities||293||492|
|Total current liabilities||17,895||7,063|
|Operating lease liabilities, non-current||—||35|
|Other non- current liabilities||—||197|
|Common Stock and additional paid-in-capital||513,552||511,091|
|Total stockholders’ equity||179,353||227,539|
|Total liabilities and stockholders’ equity||$||197,248||$||234,834|
Source: Cassava Sciences, Inc.