Washington, D.C. 20549

Form 8-K


Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): October 29, 2019  

Cassava Sciences, Inc.
(Exact Name of Registrant as Specified in Charter)

Delaware 000-2995991-1911336
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)


7801 N Capital of Texas Highway, Suite 260, Austin, TX 78731
(Address of Principal Executive Offices) (Zip Code)

(Registrant's telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 [   ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 [   ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 [   ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 [   ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class 



 Name of each exchange on which registered
Common Stock, $0.001 par value SAVA NASDAQ Capital Market


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [   ]


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [   ]


Item 2.02. Results of Operations and Financial Condition.

On October 29, 2019, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information provided in this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. Such information shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in such filing.

Item 9.01. Financial Statements and Exhibits.

Exhibit 99.1. Press release dated October 29, 2019


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 Cassava Sciences, Inc.
Date: October 29, 2019By: /s/ Eric J. Schoen        
  Eric J. Schoen
  Chief Financial Officer



Cassava Sciences Announces Recent Clinical Highlights and Third Quarter 2019 Financial Results

- 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.”    

Clinical Highlights

Financial Highlights

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.

About Alzheimer's Disease
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

About 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 OfficerKirsten Thomas, SVP 
Cassava Sciences, Inc. The Ruth Group
eschoen@CassavaSciences.com kthomas@TheRuthGroup.com 
(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 –

(unaudited, in thousands, except per share amounts)
 Three months ended September 30, Nine months ended September 30,
 2019   2018  2019  2018 
Operating expenses           
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 
Operating loss (779)  (1,284)  (3,383)  (5,912)
Interest income 82  $
17   268   32 
Net loss$(697) $(1,267) $(3,115) $(5,880)
Net loss per share, basic and diluted$(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 


(unaudited, in thousands)
 September 30,
 December 31,
Current assets     
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    
Other assets 12   12 
Total assets$18,375  $20,139 
Liabilities and stockholders' equity     
Current liabilities     
Accounts payable$340  $294 
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    
Total liabilities 930   511 
Stockholders' equity     
Common Stock and additional paid-in-capital 184,516   183,584 
Accumulated deficit (167,071)  (163,956)
Total stockholders' equity 17,445   19,628 
Total liabilities and stockholders' equity$18,375  $20,139