Loading, Please Wait...
- Phase 2a Study Showed Statistically Significant Decreases (p<0.001) in Clinical Biomarkers of Alzheimer’s Disease -
- Phase 2b Study in Patients with Alzheimer’s Disease Initiated in Multiple Clinical Sites -
- Clinical Results in Alzheimer’s Disease Selected as Late-Breaking News at CTAD 2019 -
AUSTIN, Texas, Oct. 29, 2019 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biopharmaceutical company focused on Alzheimer’s disease, today announced recent clinical highlights and reported financial results for the third quarter ended September 30, 2019.
Net loss for the third quarter 2019 was $0.7 million, or $0.04 per share, as compared to a net loss of $1.3 million, or $0.11 per share, for the same period in 2018. Net cash used was $0.7 million during the third quarter of 2019. Cassava Sciences ended the third quarter 2019 with $17.8 million of cash and equivalents, and no debt.
“Cassava Sciences had a productive quarter with our clinical research program in Alzheimer’s,” said Remi Barbier, President & CEO. “We are encouraged by the robust biomarker data from a Phase 2a study in Alzheimer’s with lead drug candidate, PTI-125. PTI-125 is a twice-daily oral drug that targets both the neurodegeneration and the inflammatory components of Alzheimer’s. We’re seeing the research community shift from an amyloid-centric view, with all its noise and confusion, to one that targets neurodegeneration and neuroinflammation. PTI-125’s mechanism of action supports this evolution in Alzheimer’s drug development. That gets us excited.”
About PTI-125 and Cassava Sciences’ Scientific Approach
The target of PTI-125 is an altered form of filamin A (FLNA), a scaffolding protein. Published studies have shown that altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. Cassava Sciences’ lead drug candidate, PTI-125, is a small molecule that restores the normal shape and function of FLNA in the brain. This action improves the function of certain receptors in the brain and exerts powerful anti-neuroinflammatory effects.
Cassava Sciences is also developing an investigational diagnostic to detect Alzheimer’s disease with a simple blood test. This program, called PTI-125Dx, also receives significant scientific and financial support from NIH.
The underlying science for Cassava Sciences’ programs in neurodegeneration is published in several prestigious peer-reviewed technical journals, including Journal of Neuroscience, Neurobiology of Aging, and Journal of Biological Chemistry. As previously announced, NIH has awarded Cassava Sciences two research grants following an in-depth, confidential review of its science and technology. These two grant awards represent up to $6.7 million of non-dilutive financing.
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. In the U.S. alone, approximately 5.8 million people are currently living with Alzheimer’s disease, and approximately 487,000 people age 65 or older will develop Alzheimer’s in 2019.1 The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, which may also result in a growing social and economic burden.2
1, 2 Source: Alzheimer’s Association. 2019 Alzheimer’s Disease Facts and Figures. Available online at: https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
Cassava Sciences, Inc.
The mission of Cassava Sciences is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Over the past ten years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease.
Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technology, without royalty obligations to any third-party.
|For More Information Contact:||For Media Inquiries Contact:|
|Eric Schoen, Chief Financial Officer||Kirsten Thomas, SVP|
|Cassava Sciences, Inc.||The Ruth Group|
|(512) 501-2450||(508) 280-6592|
Cautionary Note Regarding Forward-Looking Statements : This press release contains “forward-looking statements” for purposes of the Private Securities Litigation Reform Act of 1995 (the Act). Cassava Sciences claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, expected cash use in future periods; statements regarding the status of Phase 2 clinical studies; the interpretation of clinical results, including potential health benefits, if any, of changes in levels of biomarkers; comments and commentaries made by its Chief Executive Officer; and other potential benefits, if any, of the Company’s product candidates for Alzheimer’s disease. The Company cautions that forward-looking statements are inherently uncertain. Such statements are based on current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the ability to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates and including those described in the section entitled “Risk Factors” in Cassava Sciences’ Annual Report on Form 10-K for the year ended December 31, 2018. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. The content of this press release is solely the responsibility of the Company and does not necessarily represent the official views of the National Institutes of Health. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov .
– Financial Tables Follow –
|CASSAVA SCIENCES, INC.|
|CONDENSED STATEMENTS OF OPERATIONS|
|(unaudited, in thousands, except per share amounts)|
|Three months ended September 30,||Nine months ended September 30,|
|Research and development, net of grant reimbursement||$||(52||)||$||436||$||830||$||2,967|
|General and administrative||831||848||2,553||2,945|
|Total operating expenses||779||1,284||3,383||5,912|
|Net loss per share, basic and diluted||$||(0.04||)||$||(0.11||)||$||(0.18||)||$||(0.69||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||17,162||11,959||17,162||8,498|
|CONDENSED BALANCE SHEETS|
|(unaudited, in thousands)|
|Cash and cash equivalents||$||17,804||$||19,807|
|Other current assets||385||233|
|Total current assets||18,189||20,040|
|Property and equipment, net||61||87|
|Operating lease right-of-use assets||113||—|
|Liabilities and stockholders' equity|
|Accrued development expense||415||156|
|Accrued compensation and benefits||55||61|
|Operating lease liabilities, current||90||—|
|Other accrued liabilities||7||—|
|Total current liabilities||907||511|
|Operating lease liabilities, non-current||23||—|
|Common Stock and additional paid-in-capital||184,516||183,584|
|Total stockholders' equity||17,445||19,628|
|Total liabilities and stockholders' equity||$||18,375||$||20,139|