UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) June 15, 2021

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Cassava Sciences, Inc.

(Exact name of registrant as specified in its charter)

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7801 N Capital of Texas Highway, Suite 260

Austin, Texas 78731

(Address of principal executive offices, including zip code)

(512) 501-2444

(Registrant’s telephone number, including area code)



Not Applicable

(Former name or former address, if changed since last report.)

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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 (see General Instruction A.2 below):

 





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





 

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

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.

 

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Item 1.01  Entry into a Material Definitive Agreement 

 

On June 15, 2021,  Cassava Sciences, Inc. (the “Company”) entered into a Master Services Agreement (MSA) with Premier Research International LLC  (Premier)  for Premier to provide clinical research organization (CRO) services to support a Phase 3 program of simufilam in Alzheimer’s disease pursuant to work orders to be issued under the MSA by mutual agreement of the parties. In addition, on June 18, 2021, the Company entered into two work orders with Premier pursuant to the MSA for certain start-up services and sub-contract pass through costs for a total of up to approximately $14.0 million, to be billed over the term of the work orders.



The MSA has an initial term of two years with automatic renewal for one-year terms, unless earlier terminated by the parties. The Company may terminate the MSA or individual work orders at any time without cause by giving Premier 60 days’ prior written notice. Either party may terminate the MSA or individual work orders upon written notice as a result of a material event of default of the MSA that remains uncured for a period of sixty days. Either party may also terminate the MSA immediately upon written notice in the event that the other party (i) files a voluntary petition in bankruptcy or has an involuntary bankruptcy petition filed against it, which is not dismissed within thirty (30) days after its institution; (ii) is adjudged as bankrupt; (iii) becomes insolvent; (iv) has a receiver, trustee, conservator or liquidator appointed for all or a substantial part of its assets; (v) ceases to do business; (vi) commences any dissolution, liquidation or winding up; or (vii) makes an assignment of its assets for the benefit of its creditors. The MSA also contains provisions regarding the rights and responsibilities of the parties with respect to CRO services, payment terms, ownership of intellectual property, confidentiality and indemnification, as well as other customary provisions.

 

The foregoing description of the MSA does not purport to be complete and is qualified in its entirety by reference to the full text of the MSA, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the fiscal period ending June 30, 2021, with confidential portions redacted.

 

 

Item 8.01    Other Events.

 

On June 21, 2021, the Company issued a press release announcing the Master Services Agreement between the Company and Premier, a copy of which is attached as Exhibit 99.1 hereto and incorporated herein by reference.



Item 9.01 Financial Statements and Exhibits. 



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SIGNATURE



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





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Cassava Sciences Selects Clinical Research Organization for Phase 3 Clinical Program in Alzheimer’s Disease



-  Selection of Premier Research as CRO Marks Significant Milestone

Toward Initiation of Phase 3  Program of Simufilam in Alzheimer’s Disease -



AUSTIN, Texas – June 21, 2021 – Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the selection of Premier Research International as its clinical research organization (CRO) to help conduct the Phase 3 clinical program of simufilam for Alzheimer’s disease. Consistent with previous guidance, Cassava Sciences plans to initiate this Phase 3 program in the second half of 2021.

   

“Having completed over 250 clinical studies in neuroscience, we believe Premier Research International understands how to conduct clinical studies in patients with Alzheimer’s disease,” said Remi Barbier, President & CEO of Cassava Sciences.  “With Premier Research as our CRO partner, we now look forward to advance simufilam into Phase 3 clinical testing.”



“Premier Research is pleased to be Cassava Sciences’ CRO of choice for this pivotal program,” said Krista Armstrong, Senior Vice President, Clinical Development Services and Global Head of Neuroscience, Premier Research. “Premier Research has deep experience in conducting complex studies in neuroscience. We look forward to bringing our extensive knowledge and experience in Alzheimer’s disease to Cassava Sciences’ pivotal Phase 3 program of simufilam.”



About Premier Research

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Premier Research, a clinical research and development company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. For more information, please visit https://premier-research.com

About Cassava Sciences, Inc.

Cassava Sciences’ mission is to discover and develop innovations for chronic, neurodegenerative conditions. Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease. For more information, please visit https://www.CassavaSciences.com



For More Information Contact: 

Eric Schoen, Chief Financial Officer

eschoen@CassavaSciences.com    

(512) 501-2450



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, relating to: Premier Research’s contributions to or ability to conduct the Company’s Phase 3 clinical program; and the Company’s current intentions to initiate a Phase 3 clinical program in Alzheimer’s disease in 2021. These statements may be identified by words such as “may,” “anticipate,” “believe,” “could,” “expect,” “would”, “forecast,” “intend,” “plan,” “possible,” “potential,” and other words and terms of similar meaning.



Drug development involves a high degree of risk, and historically only a small number of research and development programs result in commercialization of a product. Clinical results from our 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, the severity and duration of health care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic 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 December 31, 2020 and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release. 



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.



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