Cassava Sciences Reports Q1 2023 Financial Results and Operating Updates
- Over 1,244 Alzheimer’s patients now enrolled in Phase 3 studies of simufilam.
- Completion of patient enrollment for Phase 3 program still expected Q4 2023.
$187.5 MillionCash and Cash Equivalents at March 31, 2023.
“In Q1 2023, we announced results of a one-year, open-label Phase 2 safety study of simufilam in over 200 patients with Alzheimer’s disease,” said
Financial Results for First Quarter 2023
March 31, 2023, cash and cash equivalents were $187.5 million, with no debt.
- Net loss was
$24.3 million, or $0.58per share. This compares to a net loss of $17.5 million, or $0.44per 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
$13.3 millionduring the first quarter of 2023.
- Net cash use in operations for the first half 2023 is now expected to be
$30to $40 million, compared to previous guidance of $45to $50 milliondue primarily to the timing of certain payment obligations for studies of simufilam.
- Research and development (R&D) expenses were
$22.1 million. This compared to $14.9 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
$4.4 million. This compared to $2.9 millionfor the same period in 2022. G&A expenses increased due primarily to increased activities and expenses related to legal services.
About Cassava Sciences’ Phase 3 Program
We are conducting a Phase 3 clinical evaluation of simufilam in people with Alzheimer’s disease dementia. This program consists of two on-going, randomized, double-blind, placebo-controlled studies. Both Phase 3 studies have received a Special Protocol Assessment (SPA) from the
Simufilam is a novel drug candidate designed to treat and slow the progression of Alzheimer’s disease. Simufilam binds tightly to an altered conformation of the filamin A protein (FLNA) that is present in the brain of the Alzheimer’s patient and is critical to the toxicity of Aβ42. Simufilam is wholly owned by
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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, that may include but are not limited to: our strategy and plans; the size and scope of our pivotal Phase 3 trial and its likelihood of success; the interpretation of clinical data generated in our open-label study; the timing of clinical results of the Cognition Maintenance Study; the treatment of Alzheimer’s disease dementia; the status of current and future clinical studies with simufilam, including anticipated patient enrollment goals in 2023 for our Phase 3 studies; the safety or efficacy of simufilam in patients; the release of evidential data by a third-party related to the biological activity of simufilam; the use of mass spectrometry as an alternative method of detection for SavaDx or the timing of new data release for SavaDx; expected cash use in future periods; verbal commentaries made by our employees; and potential benefits, if any, of the 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 and SavaDx are investigational product candidates. They are not approved by any regulatory authority and their safety, efficacy or other desirable attributes have not been established in patients. 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, clinical evidence of therapeutic safety or benefit for simufilam.
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
|Research and development, net of grant reimbursement||$||22,120||$||14,906|
|General and administrative||4,392||2,915|
|Total operating expenses||26,512||17,821|
|Other income, net||190||263|
|Net loss per share, basic and diluted||$||(0.58||)||$||(0.44||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||41,739||39,962|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||187,467||$||201,015|
|Prepaid expenses and other current assets||7,532||10,211|
|Total current assets||194,999||211,226|
|Property and equipment, net||22,609||22,864|
|Operating lease right-of-use assets||—||122|
|Intangible assets, net||503||622|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||8,242||$||4,017|
|Accrued development expense||5,276||2,280|
|Accrued compensation and benefits||212||170|
|Operating lease liabilities, current||—||104|
|Other accrued liabilities||179||492|
|Total current liabilities||13,909||7,063|
|Operating lease liabilities, non-current||—||35|
|Other non- current liabilities||197||197|
|Common Stock and additional paid-in-capital||511,828||511,091|
|Total stockholders' equity||204,005||227,539|
|Total liabilities and stockholders' equity||$||218,111||$||234,834|
Source: Cassava Sciences, Inc.