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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported) July 01, 2024
Cassava
Sciences, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-41905 |
|
91-1911336
|
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
Number) |
6801
N Capital of Texas Highway, Building 1; Suite 300
Austin,
Texas 78731
(Address
of principal executive offices, including zip code)
(512)
501-2444
(Registrant’s
telephone number, including area code)
(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 (see General Instruction A.2 below):
☐ |
Written
communication 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
communication pursuant to Rule 14d-2(b) under the Exchange Act (17CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communication pursuant to Rule 13e-4(c) under the Exchange Act (17CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.001 par value |
|
SAVA |
|
Nasdaq
Capital Market |
Warrants,
exercisable for shares of Common Stock* |
|
SAVAW |
|
Nasdaq
Capital Market |
*
In connection with the redemption of the Warrants on May 7, 2024, Nasdaq Stock Market LLC has filed a Form 25 relating to their removal
from listing and deregistration under 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. ☐
Item
8.01. Other Events.
Update
on Government Investigations
Cassava
Sciences, Inc. (“Cassava” or the “Company”) has been engaging with the U.S. Department of Justice (the “DOJ”)
and the U.S. Securities and Exchange Commission (the “SEC”) in connection with ongoing investigations into the Company and
two senior employees of the Company. Cassava is cooperating with the DOJ and SEC in connection with these investigations.
In
the course of ongoing discussions with the SEC regarding the Company’s Phase 2b study of simufilam in Alzheimer’s disease
(the “Phase 2b Study”), the SEC recently provided the Company with new information obtained during its investigation. The
Company’s Board of Directors (the “Board”) has empowered an Ad Hoc Investigation Committee (the “Committee”),
comprising independent directors, to direct an investigation (the “Internal Investigation”) of the information provided by
the SEC. The Internal Investigation is also evaluating information contained in the DOJ indictment of Dr. Hoau-Yan Wang discussed below.
This Committee, with the assistance of the Company’s General Counsel, is supervising outside counsel conducting the Internal Investigation.
The Committee is also empowered to oversee the Company’s disclosures in filings with the SEC regarding matters at issue in the
Internal Investigation. The Internal Investigation is continuing.
Indictment
of Dr. Hoau-Yan Wang
On
June 28, 2024, the DOJ announced that a federal grand jury in the U.S. District Court for the District of Maryland returned an indictment
of Dr. Wang. The indictment alleges that Dr. Wang caused Cassava to submit grant applications to the U.S. National Institutes of Health
(“NIH”) that contained false and fraudulent representations about his research. Among other things, the indictment alleges
that Dr. Wang made materially false, fraudulent, and misleading statements to NIH regarding the mechanism by which the Company’s
therapeutic product candidate, simufilam, was designed to treat Alzheimer’s disease and the improvement of certain Alzheimer’s
disease indicators in patients treated with simufilam, and that Dr. Wang manipulated or otherwise fabricated research results, including
Western Blot images that he prepared.
Dr.
Wang, who is employed as a professor at the School of Medicine of the City University of New York (“CUNY”), previously served
as a scientific collaborator and advisor to Cassava. Dr. Wang’s research, including foundational research published together with
Dr. Lindsay Burns, Cassava’s SVP, Neuroscience, led to the discovery of simufilam. Among other work for Cassava, Dr. Wang’s
laboratory at CUNY conducted the final bioanalysis for the Phase 2b Study, which the Company reported as part of the final results of
the Phase 2b Study.
Dr.
Wang received compensation from the Company for his consulting and advisory work for Cassava. For over a decade until Cassava’s
termination of its consulting relationship with him, Dr. Wang was paid a cash stipend of $2,000 per month. He has also been awarded
stock options pursuant to the Company’s equity incentive plans, none of which have been exercised through the date of this report.
As of the date of this report, Dr. Wang holds 18,571 stock options, all of which were granted between 2015 and 2019 and are fully
vested, with a weighted average exercise price of $4.22 per share. Dr. Wang was previously a participant in the Company’s cash
incentive bonus plan (the “Cash Incentive Plan”), during which time the Company achieved target valuation milestones that
established aggregate bonus payment amounts. The determination whether to make any payments of such amounts to participants and, if so,
the allocation of amounts among participants (other than the Company’s chief executive officer), remains subject to the discretion
of the Compensation Committee of the Board. In all cases, the payment of cash bonuses under the Cash Incentive Plan is subject to
(i) Cassava’s completion of a merger transaction or (2) the determination by the Compensation Committee of the Board that the Company
has sufficient cash on hand to render such payment, neither of which may ever occur. To date, Dr. Wang has not been allocated any
cash bonus payment pursuant to the Cash Incentive Plan. The Company has not paid any cash bonus to Dr. Wang or to any other participant
under the Cash Incentive Plan as of the date of this report. Prior to Dr. Wang’s indictment, the Company terminated its consulting
relationship with him, and the Board removed him as a participant in the Cash Incentive Plan.
Supplemental
Disclosures
Based
on the Committee’s preliminary review of information gathered in the Internal Investigation to date, the Company is supplementing
its prior disclosures, initially reported in September 2020, regarding the Phase 2b Study.
The
Phase 2b Study was designed as a 28-day, approximately 60-patient, randomized, double-blind, placebo-controlled, multiple dose study.
One objective of the Phase 2b Study was to measure changes in levels of cerebrospinal fluid (“CSF”) biomarkers in study participants
from baseline value to Day 28. Based on CSF biomarker assays and bioanalysis conducted by Dr. Wang, Cassava reported statistically significant
improvements in biomarkers in treatment groups as compared to the placebo group. To date, the Internal Investigation has determined that
certain statistical information contained in an attachment to an email sent by a senior employee of Cassava to Dr. Wang before the bioanalysis
could have been used to unblind him as to some number of Phase 2b Study participants.
Another
objective of the Phase 2b Study was to measure changes in cognitive outcome measures using the Cambridge Neuropsychological Test Automated
Battery, or CANTAB, (a validated, computer-based battery of tests) over the 28-day study period. Neither Dr. Wang nor his laboratory
at CUNY was involved in the cognition portion of the Phase 2b Study.
With
respect to the cognition portion of the Phase 2b Study, Cassava is reporting in this 8-K information regarding its post hoc statistical
analysis with respect to selected CANTAB outcome measures for the Phase 2b Study. This information was previously disclosed in a draft
preprint manuscript that was publicly available as of the first quarter of 2021. The Phase 2b Study’s CANTAB tests were not powered
for statistical significance and were therefore evaluated only for effect size.
In
September 2020, the Company reported on study participants’ episodic memory and spatial working memory, as assessed using CANTAB,
over the 28-day study period. The Company reported the primary outcome measurements of Paired Associates Learning total errors adjusted,
in respect of episodic memory, and total errors in respect of Spatial Working Memory. Other outcome measurements that were generated
by the CANTAB tests were not reported by the Company.
Although
the 28-day Phase 2b Study enrolled 64 patients, the statistical analysis of the CANTAB outcome measurements reported by the Company reflected
certain study participant exclusions. With respect to the analysis of episodic memory measures, approximately 42% of study participants
were excluded from the reported analysis (approximately 38% of study participants from the 50 mg arm, approximately 52% of study participants
from the 100 mg arm and approximately 36% from the placebo arm). For these episodic memory test exclusions, the most and least impaired
subjects were excluded by baseline score (≤ 11 or ≥ 54 out of 70 total possible errors) before the effect size was calculated.
These cutoffs were employed to remove subjects with very few errors (ceiling effects), as well as subjects who performed so poorly that
they may not have understood the task evaluated by the test. Analysis of both CANTAB test data sets also excluded subjects with no detectable
plasma simufilam (3 patients) (i.e., treatment arm study participants who did not appear to have taken simufilam), patients who
were ≥25% noncompliant with the study’s treatment regimen by pill counts (2 patients), patients with no baseline test (1 patient),
and patients who, according to study investigators, did not understand the test instructions (1 patient). Accordingly, reported results
reflected N=14, 13, 10 for episodic memory, and N=22, 17, 18 for spatial working memory for placebo, 50 and 100 mg, respectively. Because
the results first reported in September 2020 reflect calculations of effect size after these exclusions, the Company’s reported
results reflect an analysis of a substantially smaller analysis-set population than the full Phase 2b Study population.
Independent
Analysis of Phase 3 Trial Data
The
Company is currently conducting two randomized, placebo-controlled Phase 3 clinical trials of oral simufilam in patients with mild-to-moderate
Alzheimer’s disease. Both trials are fully enrolled. The trials have randomized a total of approximately 1,900 patients with mild-to-moderate
Alzheimer’s disease at baseline. All efficacy data from the Company’s Phase 3 program remain blinded. There are no interim
analyses on efficacy outcomes.
Phase
3 data and samples for bioanalysis will be directly provided to and analyzed by independent, third-party commercial consulting firms.
Neither Dr. Wang nor his laboratory at CUNY has any involvement in the Company’s ongoing Phase 3 clinical trials of simufilam.
Cautionary
Note Regarding Forward-Looking Statements:
This
report 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 statements regarding: ongoing government investigations, the Company’s
ongoing Internal Investigation, and potential findings or outcomes of such investigations; statements relating to clinical trials of
Cassava’s product candidates; and statements relating to the potential benefits, if any, of Cassava’s product candidates.
These statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,”
“forecast,” “intend,” “may,” “plan,” “possible,” “potential,”
“will,” and other words and terms of similar meaning. Such statements are subject to a number of risks, uncertainties and
assumptions, including, but not limited to, those described in the section entitled “Risk Factors” in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2023, and future reports filed with the SEC. In light of these risks, uncertainties
and assumptions, the forward-looking statements and events discussed in this report 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, the Company disclaims any intention
or responsibility for updating or revising any forward-looking statements.
Cassava’s
clinical results from earlier-stage clinical trials may not be indicative of future 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 the Company
presents or publishes or has presented or published previously.
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.
|
CASSAVA
SCIENCES, INC. |
|
a
Delaware corporation |
|
|
|
Date:
July 01, 2024 |
|
|
|
By: |
/s/
Eric J. Schoen |
|
|
Eric
J. Schoen |
|
|
Chief
Financial Officer |
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