Case 1:21-cv-00971 Document 1 Filed 10/26/21 Page 1 of 33
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`UNITED STATES DISTRICT COURT
`WESTERN DISTRICT OF TEXAS
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`MANOHAR K. RAO, Individually and On
`Behalf of All Others Similarly Situated,
`
`Plaintiff,
`
`v.
`
`Case No. 1:21-cv-00971
`
`CLASS ACTION COMPLAINT FOR
`VIOLATIONS OF THE FEDERAL
`SECURITIES LAWS
`
`CASSAVA SCIENCES, INC., REMI
`BARBIER, and ERIC J. SCHOEN,
`
`JURY TRIAL DEMANDED
`
`Defendants.
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`Case 1:21-cv-00971 Document 1 Filed 10/26/21 Page 2 of 33
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`Plaintiff Manohar K. Rao (“Plaintiff”), individually and on behalf of all others similarly
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`situated, by and through his attorneys, alleges the following upon information and belief, except
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`as to those allegations concerning Plaintiff, which are alleged upon personal knowledge. Plaintiff’s
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`information and belief is based upon, among other things, her counsel’s investigation, which
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`includes without limitation: (a) review and analysis of regulatory filings made by Cassava
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`Sciences, Inc. (“Cassava” or the “Company”) with the United States (“U.S.”) Securities and
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`Exchange Commission (“SEC”); (b) review and analysis of press releases and media reports issued
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`by and disseminated by Cassava; and (c) review of other publicly available information concerning
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`Cassava.
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`NATURE OF THE ACTION AND OVERVIEW
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`1.
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`This is a class action on behalf of persons and entities that purchased or otherwise
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`acquired Cassava securities, and/or sold (wrote) Cassava put options, between September 14, 2020
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`and August 27, 2021, inclusive (the “Class Period”). Plaintiff pursues claims against the
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`Defendants under the Securities Exchange Act of 1934 (the “Exchange Act”).
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`2.
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`Cassava is a clinical stage biotechnology company. Its lead therapeutic product
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`candidate is called simufilam (formerly PTI-125) developed as a treatment for Alzheimer’s disease
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`(“AD”). Simufilam purportedly targets an altered form of a protein called filamin A (“FLNA”) in
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`the Alzehimer’s brain and reverts it to its native, healthy conformation, thereby countering the
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`downstream toxic effects of altered FLNA.
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`3.
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`On August 24, 2021, after the market closed, reports emerged about a citizen
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`petition submitted to the U.S. Food and Drug Administration (“FDA”) concerning the accuracy
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`and integrity of clinical data for simufilam. The petition requested that the FDA halt Cassava’s
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`clinical trials pending a thorough audit of the publications and data relied upon by the Company.
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`Among other things, the petition stated that the “[d]etailed analysis of the western blots [relied on
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`by Cassava to support the connection between simufilam and Alzheimer’s] shows a series of
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`anomalies that are suggestive of systematic data manipulation and misrepresentation.” It also
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`stated that the methodology for studies “about Simufilam’s effects in experiments conducted on
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`postmortem human brain tissue . . . defies logic, and the data presented again have hallmarks of
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`manipulation.” The petition further stated that, after initial analyses of Phase 2b trials found that
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`Simufilam was ineffective in improving the primary biomarkers endpoint, “Cassava had these
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`samples analyzed again and this time reported that Simufilam rapidly and robustly improved a
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`wide array of biomarkers” and the reanalysis “shows signs of data anomalies or manipulation.”
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`4.
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`On August 25, 2021, before the market opened, Cassava issued a response to the
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`petition, claiming that the allegations regarding scientific integrity are false and misleading.
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`Among other things, the Company claimed that the clinical data, which the citizen petition stated
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`had been reanalyzed to show simufilam was effective, had been generated by Quanterix Corp.
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`(“Quanterix”), an independent company, suggesting that the reanalysis was valid.
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`5.
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` On this news, the Company’s share price fell $36.97, or 32%, to close at $80.86
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`per share on August 25, 2021, on unusually heavy trading volume.
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`6.
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`On August 27, 2021, before the market opened, Quanterix issued a statement
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`denying the Company’s claims, stating that it “did not interpret the test results or prepare the data”
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`touted by Cassava.
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`7.
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`The same day, Cassava responded to Quanterix’s statement, stating that
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`“Quanterix’[s] sole responsibility with regard to this clinical study was to perform sample testing,
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`specifically, to measure levels of p-tau in plasma samples collected from study subjects.”
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`8.
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`On this news, the Company’s share price fell $12.51, or 17.6%, to close at $58.34
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`per share on August 27, 2021, on unusually heavy trading volume.
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`9.
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`Throughout the Class Period, Defendants made materially false and/or misleading
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`statements, as well as failed to disclose material adverse facts about the Company’s business,
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`operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that data
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`underlying the foundational research for Cassava’s product candidates had been manipulated; (2)
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`that experiments using post-mortem human brain tissue frozen for nearly 10 years was contrary to
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`a basic understanding of neurobiology; (3) that biomarker analysis for patients treated with
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`simufilam had been manipulated to conclude that simufilam was effective; (4) that Quanterix, an
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`independent company, had not interpreted the test results or prepared the data charts for the
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`biomarker analysis for patients treated with simufilam; (5) that, as a result of the foregoing, there
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`was a reasonable likelihood that Cassava would face regulatory scrutiny in connection with the
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`development of simufilam; and (6) that, as a result of the foregoing, Defendants’ positive
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`statements about the Company’s business, operations, and prospects were materially misleading
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`and/or lacked a reasonable basis.
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`10.
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`As a result of Defendants’ wrongful acts and omissions, and the precipitous decline
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`in the market value of the Company’s shares, Plaintiff and other Class members have suffered
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`significant losses and damages.
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`JURISDICTION AND VENUE
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`11.
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`The claims asserted herein arise under Sections 10(b) and 20(a) of the Exchange
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`Act (15 U.S.C. §§ 78j(b) and 78t(a)) and Rule 10b-5 promulgated thereunder by the SEC (17
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`C.F.R. § 240.10b-5).
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`12.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. § 1331 and Section 27 of the Exchange Act (15 U.S.C. § 78aa).
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`13.
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`Venue is proper in this Judicial District pursuant to 28 U.S.C. § 1391(b) and Section
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`27 of the Exchange Act (15 U.S.C. § 78aa(c)). Substantial acts in furtherance of the alleged fraud
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`or the effects of the fraud have occurred in this Judicial District. Many of the acts charged herein,
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`including the dissemination of materially false and/or misleading information, occurred in
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`substantial part in this Judicial District. In addition, the Company’s principal executive offices are
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`located in this District.
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`14.
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`In connection with the acts, transactions, and conduct alleged herein, Defendants
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`directly and indirectly used the means and instrumentalities of interstate commerce, including the
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`United States mail, interstate telephone communications, and the facilities of a national securities
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`exchange.
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`PARTIES
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`15.
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`Plaintiff Manohar K. Rao, as set forth in the accompanying certification,
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`incorporated by reference herein, purchased Cassava securities and sold Cassava put options
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`during the Class Period, and suffered damages as a result of the federal securities law violations
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`and false and/or misleading statements and/or material omissions alleged herein.
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`16.
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`Defendant Cassava is incorporated under the laws of Delaware with its principal
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`executive offices located in Austin, Texas. Cassava’s common stock trades on the NASDAQ under
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`the symbol “SAVA.”
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`17.
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`Defendant Remi Barbier (“Barbier”) was the Chief Executive Officer (“CEO”),
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`President, and Chairman of the Board of Directors of Cassava at all relevant times.
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`18.
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`Defendant Eric J. Schoen (“Schoen”) was the Chief Financial Officer (“CFO”) of
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`Cassava at all relevant times.
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`19.
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`Defendants Barbier and Schoen (collectively the “Individual Defendants”), because
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`of their positions with the Company, possessed the power and authority to control the contents of
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`the Company’s reports to the SEC, press releases and presentations to securities analysts, money
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`and portfolio managers and institutional investors, i.e., the market. The Individual Defendants
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`were provided with copies of the Company’s reports and press releases alleged herein to be
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`misleading prior to, or shortly after, their issuance and had the ability and opportunity to prevent
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`their issuance or cause them to be corrected. Because of their positions and access to material non-
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`public information available to them, the Individual Defendants knew that the adverse facts
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`specified herein had not been disclosed to, and were being concealed from, the public, and that the
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`positive representations which were being made were then materially false and/or misleading. The
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`Individual Defendants are liable for the false statements pleaded herein.
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`SUBSTANTIVE ALLEGATIONS
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`Background
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`20.
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`Cassava is a clinical stage biotechnology company. Its lead therapeutic product
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`candidate is called simufilam (formerly PTI-125) developed as a treatment for Alzheimer’s disease
`
`(“AD”). Simufilam purportedly targets an altered form of a protein called filamin A (“FLNA”) in
`
`the Alzehimer’s brain and reverts it to its native, healthy conformation, thereby countering the
`
`downstream toxic effects of altered FLNA.
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`Materially False and Misleading
`Statements Issued During the Class Period
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`21.
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`The Class Period begins on September 14, 2020. On that day, Cassava announced
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`the final results from its Phase 2b clinical study of simufilam in a press release that stated, in
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`relevant part:1
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`Cassava Sciences, Inc. (Nasdaq: SAVA) today announced final results of a Phase
`2b study with its lead drug candidate, sumifilam [sic], in Alzheimer’s disease. In a
`clinical study funded by the National Institutes of Health (NIH), sumifilam
`significantly improved an entire panel of validated biomarkers of disease in
`patients with Alzheimer’s disease. The ability to improve multiple biomarkers
`from distinct biological pathways with one drug has never been shown before in
`patients with Alzheimer’s disease. Study results are expected to be published in a
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`1 Unless otherwise stated, all emphasis herein is added.
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`peer-reviewed publication. Sumifilam is the first of a new class of drug compounds
`that bind to a protein called Filamin A.
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`“Filamin-binding molecules are new to Alzheimer’s research and may represent an
`important advance if these data can be replicated in larger studies,” said Jeffrey
`Cummings, M.D., Sc.D., Founding Director of the Cleveland Clinic Lou Ruvo
`Center for Brain Health, and Chambers Professor of Brain Science at the University
`of Nevada, Las Vegas. “I am pleased to see early evidence of disease-modifying
`effects in patients with this investigational drug. The data appear to represent a step
`forward toward urgently needed treatments for Alzheimer’s disease.”
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`In addition, Alzheimer’s patients treated with sumifilam showed directional
`improvements in tests of remembering new information, versus patients on placebo.
`Improvements in cognition correlated most strongly with decreases in P-tau181, a
`biomarker that, when elevated, leads to tangles in the brain. Sumifilam decreased
`brain levels of Ptau-181 by 8-11%, versus placebo.
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`In this study, Alzheimer’s patients treated with 50 mg or 100 mg of sumifilam
`twice-daily for 28 days showed statistically significant (p<0.05) improvements in
`biomarkers of disease pathology, neurodegeneration and neuroinflammation,
`versus Alzheimer’s patients who took placebo. In addition, Alzheimer’s patients
`treated with sumifilam showed directional improvements in validated tests of
`episodic memory and spatial working memory, versus patients on placebo (Effect
`Sizes 46-17%). Cognitive improvements correlated most strongly (R2=0.5) with
`decreases in P-tau181. The study achieved a 98% response rate, defined as the
`proportion of study participants taking sumifilam who showed improvements in
`biomarkers.
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`“The clinical data suggest sumifilam may be slowing disease progression in
`Alzheimer’s patients,” said Nadav Friedmann, PhD/MD, Chief Medical Officer,
`Cassava Sciences. “This exciting possibility will need to be evaluated in future
`collaborations with patients, physicians, advisors and others.”
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`“Other than a few drugs to help ease the decline, there’s really nothing out there to
`treat people with Alzheimer’s,” said Remi Barbier, Chairman, President & CEO,
`Cassava Sciences. “The improvement on multiple biomarkers in this clinical study
`is a first and offers hope that sumifilam has potential to become a transformative
`treatment for people with Alzheimer’s disease.”
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`22.
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`On February 2, 2021, Cassava announced that Simufilam improves cognition and
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`behavior in Alzheimer’s disease according to the interim analysis from an open-label study.
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`Specifically, the Company stated, in relevant part:
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`Cassava Sciences, Inc. (Nasdaq: SAVA) today announced results of an interim
`analysis from an open-label study of simufilam, its lead drug candidate for the
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`treatment of Alzheimer’s disease. Patients’ cognition and behavior scores both
`improved following six months of simufilam treatment, with no safety issues.
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`In a clinical study funded by the National Institutes of Health and conducted by
`Cassava Sciences, six months of simufilam treatment improved cognition scores by
`1.6 points on ADAS-Cog11, a 10% mean improvement from baseline to month 6.
`In these same patients, simufilam also improved dementia-related behavior, such
`as anxiety, delusions and agitation, by 1.3 points on the Neuropsychiatric Inventory,
`a 29% mean improvement from baseline to month 6.
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`Alzheimer’s is a progressive disease. Over time, a patient’s cognition will always
`worsen. “Experience based on longitudinal studies of ambulatory patients with mild
`to moderate Alzheimer’s disease suggest that scores on ADAS-cog decline by 6 -
`12 points per year”, according to FDA’s Prescription Information sheet for
`ARICEPT® (donepezil), a drug approved for the treatment of dementia of the
`Alzheimer’s type1.
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`“We could not be more pleased with these interim results,” said Remi Barbier,
`President & CEO. “We would have been satisfied to show simufilam stabilizes
`cognition in patients over 6 months. An improvement in cognition and behavior
`tells us this drug candidate has potential to provide lasting treatment effects for
`people living with Alzheimer’s disease. It’s an exciting development.”
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`The safety profile of simufilam in the interim analysis was consistent with prior
`human studies. There were no drug-related serious adverse events. Adverse events
`were mild and transient.
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`“Today’s data once again suggests simufilam could be a transformative, novel
`therapeutic,” added Nadav Friedmann, PhD, MD, Chief Medical Officer. “It
`appears the drug’s unique mechanism of action has potential to provide a treatment
`benefit following 6 months of dosing.”
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`23.
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`On February 22, 2021, Cassava issued a press release entitled “Cassava Sciences
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`Announces Positive End-of-Phase 2 Meeting with the FDA and Outlines Pivotal Phase 3 Program
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`for Simufilam in Alzheimer’s Disease.” It stated in relevant part:
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`Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company developing
`product candidates for Alzheimer’s disease, today announced the successful
`completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug
`Administration (FDA) for simufilam, its lead drug candidate for the treatment of
`Alzheimer’s disease. Official EOP2 meeting minutes indicate FDA and Cassava
`Sciences agree on key elements of a pivotal Phase 3 clinical program in support of
`a New Drug Application (NDA) filing for simufilam in Alzheimer’s disease.
`Agreements reached during the EOP2 meeting show a clear path forward for
`advancing simufilam into Phase 3 studies in the second half of 2021.
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`Official meeting minutes confirm that Cassava Sciences and FDA are aligned on
`key elements of a Phase 3 clinical program for simufilam. FDA has agreed that
`the completed Phase 2 program, together with an upcoming and well-defined
`Phase 3 clinical program, are sufficient to show evidence of clinical efficacy for
`simufilam in Alzheimer’s disease. There is also agreement that the use of separate
`clinical scales to assess cognition (ADAS-cog1) and function (ADCS-ADL2) are
`appropriate co-primary endpoints of efficacy. A clinical scale that combines
`cognition and function, such as iADRS3, is a secondary efficacy endpoint.
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`24.
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`On March 23, 2021, Cassava announced its full year 2020 financial results in a
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`press release that stated, in relevant part:
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`“In Q1 2021 we announced that our lead drug candidate, simufilam, improved
`cognition scores in 50 patients with Alzheimer’s disease who completed at least 6
`months of open-label treatment,” said Remi Barbier, President & CEO. “In mid-
`2021, we look forward to announcing cognition scores in patients who’ll have
`completed at least 12 months of open-label treatment with simufilam. To our
`knowledge, no drug has stabilized, much less improved, cognition scores over 12
`months in patients with Alzheimer’s disease. For this reason, I feel there is a sense
`of anticipation around the upcoming release of 12-month clinical data from our
`open-label study, as well as our plans to conduct a pivotal Phase 3 program with
`simufilam in the second half of 2021. With solid science, the right people in place,
`cash in the bank and a clinical roadmap that makes sense, I think Cassava
`Sciences is positioned to becoming a premier organization to serve patients with
`Alzheimer’s disease.”
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`25.
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`The same day, Cassava filed its annual report on Form 10-K for the period ended
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`December 31, 2020 (the “2020 10-K”), affirming the previously reported financial results. The
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`Company further stated:
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`Since 2017, we have concentrated a substantial portion of our research and
`development efforts on the treatment and detection of Alzheimer’s disease, an
`area of research that has seen significant failure rates. Further, our product
`candidates are based on new scientific approaches and novel technology, which
`makes it difficult to predict the time and cost of product candidate development
`and likelihood of success.
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`Since 2017, we have concentrated a substantial portion of our research and
`development efforts on experimental methods for the treatment and detection of
`Alzheimer’s disease. Prior efforts by biopharmaceutical companies to develop new
`treatments for Alzheimer’s disease have seen very limited clinical success. No new
`treatments have been approved for Alzheimer’s disease since 2003, and since that
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`time, while many large clinical studies have been completed, no drug candidate has
`shown clear evidence of clinical efficacy in large, Phase 3 clinical studies. FDA-
`approved drugs for Alzheimer’s disease only address symptoms, and there are no
`FDA-approved disease modifying therapeutics available for patients with
`Alzheimer’s disease. Notwithstanding these substantial challenges to date, we seek
`to
`improve brain health by addressing
`the neurodegeneration and
`neuroinflammation components of Alzheimer’s disease. Our lead drug candidate
`for Alzheimer’s disease is based on a new approach of stabilizing – but not
`removing – a critical protein in the brain. We cannot be certain that our novel
`technologies will lead to an approvable or marketable product. In addition, because
`FDA has limited comparators to evaluate our lead drug candidate, we could
`experience a longer than expected regulatory review process and increased
`development costs.
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`26.
`
`The 2020 10-K further stated:
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`Our clinical studies may fail to demonstrate substantial evidence of the safety and
`efficacy of our product candidates, which would prevent, delay, or limit the scope
`of regulatory approval and commercialization.
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`*
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`*
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`*
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`Clinical testing is expensive and can take many years to complete, and its outcome
`is inherently uncertain. Failure can occur at any time during the clinical study
`process. The results of preclinical studies of our product candidates may not be
`predictive of the results of early-stage or later-stage clinical studies, and results of
`early clinical studies of our product candidates may not be predictive of the results
`of later-stage clinical studies. The results of clinical studies in one set of patients or
`disease indications may not be predictive of those obtained in another. In some
`instances, there can be significant variability in safety or efficacy results between
`different clinical studies of the same product candidate due to numerous factors,
`including changes in study procedures set forth in protocols, differences in the size
`and type of the patient populations, changes in and adherence to the dosing regimen,
`and other clinical study protocols and the rate of dropout among clinical study
`participants. Open-label extension studies may also extend the timing and cost of a
`clinical study substantially. Product candidates in later stages of clinical studies
`may fail to show the desired safety and efficacy profile despite having progressed
`through preclinical studies and initial clinical studies. Many companies in the
`biopharmaceutical industry have suffered significant setbacks in advanced clinical
`studies due to lack of efficacy or unacceptable safety issues, notwithstanding
`promising results in earlier studies. This is particularly true in neurodegenerative
`diseases, where failure rates historically have been higher than in many other
`disease areas. Most product candidates that begin clinical studies are never
`approved by regulatory authorities for commercialization.
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`*
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`*
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`*
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`In addition, even if such clinical studies are successfully completed, we cannot
`guarantee that FDA or foreign regulatory authorities will interpret the results as we
`do, and more studies could be required before we submit our product candidates for
`approval. To the extent that the results of the studies are not satisfactory to FDA or
`foreign regulatory authorities for support of a marketing application, we may be
`required to expend significant resources, which may not be available to us, to
`conduct additional studies in support of potential approval of our product
`candidates. Even if regulatory approval is secured for any of our product
`candidates, the terms of such approval may limit the scope and use of our product
`candidates, which may also limit its commercial potential.
`
`27.
`
`On April 21, 2021, Cassava issued a press release announcing its first quarter 2021
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`financial results, which stated in relevant part:
`
`Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company
`focused on Alzheimer’s disease, today announced financial results for the first
`quarter ended March 31, 2021 and guidance regarding the release of new clinical
`data with simufilam. Simufilam is the Company’s lead drug candidate to treat
`Alzheimer’s disease.
`
`“Alzheimer’s is a progressive disease, so a patient’s cognition is expected to worsen
`over time,” said Remi Barbier, President & CEO. “Patients’ cognition scores
`actually improved following 6 months of open-label treatment with simufilam.
`Showing similar drug effects following 9 months of open-label treatment would be
`remarkable, yet consistent with simufilam’s mechanism of action. Eventually, we’d
`like this drug candidate to benefit cognition for a year or longer.”
`
`28.
`
`On July 26, 2021, Cassava issued a press release announcing “positive data with
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`SavaDx from a randomized controlled Phase 2b study of Simufilam,” stating in relevant part:
`
`• SavaDx Detected Significant Changes in Plasma Levels of Altered Filamin
`A in Patients with Alzheimer’s Disease Before and After Simufilam
`Treatment
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`• Simufilam 100 mg and 50 mg Reduced Plasma Levels of Altered Filamin
`A in Alzheimer’s Patients 48% (p=0.003) and 44% (p=0.02) Respectively
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`• Plasma Results with SavaDx Track Plasma Results with p-Tau181
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`• Plasma Data Provide Evidence of Target Engagement
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`Cassava Sciences, Inc. (Nasdaq: SAVA) today announced positive clinical data
`with SavaDx, an investigational diagnostic/biomarker to detect Alzheimer’s
`disease with a simple blood test. SavaDx was used to measure plasma levels of
`altered filamin A before and after simufilam treatment in patients with Alzheimer’s
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`disease. In this Phase 2b randomized, controlled trial sponsored by the National
`Institutes of Health (NIH), simufilam significantly reduced plasma levels of altered
`filamin A in Alzheimer’s patients treated for 28 days. Plasma levels of p-tau181
`also dropped significantly in these same patients.
`
`Simufilam 100 mg and 50 mg reduced plasma levels of altered filamin A by 48%
`(p=0.003) and 44% (p=0.02) respectively, versus placebo. Additionally, simufilam
`100 mg and 50 mg reduced plasma levels of p-tau181 by 17% (p=0.01) and 15%
`(p=0.02) respectively, versus placebo. Plasma p-tau181 is a biomarker that is
`known to be elevated in Alzheimer’s disease.
`
`“We believe altered filamin A is a major culprit in Alzheimer’s disease,” said Remi
`Barbier, President & CEO. “Before simufilam treatment, SavaDx detected high
`plasma levels of altered filamin A in patients. After simufilam treatment, levels
`dropped significantly. We believe these data provide clear evidence that simufilam
`binds to and engages its intended target to produce treatment effects.”
`
`Treatment effects on CSF biomarkers for this Phase 2b study have been previously
`reported.
`
`29.
`
`On July 29, 2021, Cassava issued a press release announcing “positive biomarker
`
`data with Simufilam in Alzheimer’s Disease,” stating in relevant part:
`
`• Simufilam Significantly Improved Biomarkers in Alzheimer’s Patients
`Treated for 6 Months
`
`• Robust Improvements Seen in All Measured Biomarkers of Disease,
`Neurodegeneration and Neuroinflammation (p< 0.00001)
`
`• Biomarker Improvements Track with Cognitive Improvements
`
`*
`
`*
`
`*
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`Cassava Sciences, Inc. (Nasdaq: SAVA) today announced positive biomarker data
`from an open-label study of simufilam, the Company’s investigational drug for the
`treatment of Alzheimer’s disease.
`
`In a clinical study funded by the National Institutes of Health (NIH), simufilam
`significantly improved all measured biomarkers in patients with Alzheimer’s
`disease following 6 months of open-label treatment. Biomarkers are objective
`biological data. There are no placebo effects.
`
`Cerebrospinal fluid (CSF) biomarkers of disease pathology, t-tau and p-tau181,
`decreased 38% and 18%, respectively (both p<0.00001). CSF biomarkers of
`neurodegeneration, neurogranin and Nfl, decreased 72% and 55%, respectively
`(both p<0.00001). CSF biomarkers of neuroinflammation, sTREM2 and YKL-40,
`decreased 65% and 44% (both p<0.00001). CSF biomarker data were collected
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`from 25 patients with mild-to-moderate Alzheimer’s disease who completed 6
`months of simufilam treatment in an on-going open-label study.
`
`“Six months of simufilam treatment robustly improved brain biomarkers,” said
`Remi Barbier, President & CEO. “In this same study simufilam also improved
`cognition. These data suggest simufilam has potential to provide durable treatment
`effects for people living with Alzheimer’s.”
`
`30.
`
`Also on July 29, 2021, Cassava issued a press release announcing “positive
`
`cognition data with Simufilam in Alzheimer’s Disease,” stating in relevant part:
`
`• Simufilam Significantly Improves Cognition in Patients with Alzheimer’s
`in Interim Analysis of Open-label Study at 9 Months
`
`• Cognition Improved 3.0 Points on ADAS-Cog at 9 Months (p<0.001)
`
`• Cognitive Improvements Track with Biomarker Improvements
`
`• No Behavior Disorders in Over 50% of Patients
`
`• No Safety Issues
`
`•
`
`Improvements in Cognition, Biomarkers and Behavior Suggest Highly
`Encouraging Treatment Effects
`
`*
`
`*
`
`*
`
`Cassava Sciences, Inc. (Nasdaq: SAVA) announced positive clinical data today
`from an interim analysis of an open-label study with simufilam, the Company’s
`investigational drug for the treatment of Alzheimer’s disease.
`
`In a clinical study funded by the National Institutes of Health (NIH), simufilam
`significantly improved cognition in Alzheimer’s patients, with no safety issues.
`Simufilam improved cognition scores 3.0 points on ADAS-Cog11, an 18% mean
`improvement, baseline to month 9 (p<0.001). This interim analysis summarizes
`clinical data from the first 50 patients with mild-to-moderate Alzheimer’s disease
`who completed 9 months of open-label simufilam treatment.
`
`Cassava Sciences believes today’s data is the first report of significant cognitive
`improvements at 9 months that also track with robust improvements in biomarkers
`in patients with Alzheimer’s.
`
`“We are very pleased with the overall consistency of data,” said Remi Barbier,
`President & CEO. “Simufilam improved cognition, biomarkers and behavior, a
`triple-win for study participants. These clinical data combined with a clean safety
`profile and easy oral administration suggest highly encouraging and durable
`treatment effects for people living with Alzheimer’s disease.”
`
`12
`
`

`

`Case 1:21-cv-00971 Document 1 Filed 10/26/21 Page 14 of 33
`
`
`
`Alzheimer’s is a progressive disease. Cognition will always decline over time. In
`patients with mild-to-moderate Alzheimer’s disease, cognition scores decline over
`4 points on ADAS-Cog over 9 months with over 90% certainty, as reported by the
`science literature1.
`
`Simufilam improved ADAS-Cog scores in 66% of patients at 9 months. An
`additional 22% of patients declined less than reported in the science literature at 9
`months. Cognition outcomes suggest simufilam’s treatment effects were broad-
`based.
`
`Alzheimer’s is often accompanied by behaviors disorders, such as anxiety, agitation
`or delusions. These may become more frequent as disease progresses. Simufilam
`reduced dementia-related behavior at 9 months on the Neuropsychiatric Inventory
`(NPI), a clinical tool widely used to measure changes in dementia-related behavior.
`
`• At baseline, 34% of study subjects had no neuropsychiatric symptoms.
`
`• At month 6, 38% of study subjects had no neuropsychiatric symptoms.
`
`• At month 9, over 50% of study subjects had no neuropsychiatric symptoms.
`
`The safety profile of simufilam in the interim analysis is consistent with prior
`human studies. There were no drug-related serious adverse events. Adverse events
`were mild and transient.
`
`“Today’s data with simufilam suggests disease modification,” added Nadav
`Friedmann, PhD, MD, Chief Medical Officer. “It appears the drug’s unique
`mechanism of action has potential to provide transformative treatment benefits
`following 9 months of dosing.”
`
`In February 2021, Cassava Sciences reported that simufilam improved cognition
`scores by 1.6 points on ADAS-Cog11, a 10% improvement, following six months
`of open-label treatment.
`
`31.
`
`The above statements identified in ¶¶ 21-30 were materially false and/or
`
`misleading, and failed to disclose material adverse facts about the Company’s business, operations,
`
`and prospects. Specifically, Defendants failed to disclose to investors: (1) that data underlying the
`
`foundational research for Cassava’s product candidates had been manipulated; (2) that experiments
`
`using post-mortem human brain tissue frozen for nearly 10 years was contrary to a basic
`
`understanding of neurobiology; (3) that biomarker analysis for patients