Form 8-K
8-K — COGNITION THERAPEUTICS INC
Accession: 0001104659-26-064863
Filed: 2026-05-21
Period: 2026-05-21
CIK: 0001455365
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — tm2615260d1_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (tm2615260d1_ex99-1.htm)
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UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): May 21, 2026
Cognition
Therapeutics, Inc.
(Exact name of registrant as specified in its
charter)
Delaware
001-40886
13-4365359
(State
or other jurisdiction of
incorporation or organization)
(Commission File Number)
(I.R.S.
Employer
Identification No.)
2500 Westchester Ave.
Purchase,
NY
10577
(Address
of principal executive offices)
(Zip
Code)
Registrant’s telephone number, including
area code: (412)
481-2210
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 (see
General Instruction A.2. below):
¨
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
Trading
Symbol
Name
of Exchange on Which
Registered
Common
Stock, par value $0.001 per share
CGTX
The
Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is
an emerging growth company 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 x
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.
On May 21, 2026,
Cognition Therapeutics, Inc. (the “Company”) issued a press release announcing the completion of its meeting with the
U.S. Food and Drug Administration for zervimesine in dementia with Lewy bodies patients with psychosis. A copy of the Company’s
press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits
are being furnished herewith:
Exhibit
No.
Document
99.1
Press Release, dated May 21, 2026.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
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.
COGNITION THERAPEUTICS, INC.
Date: May 21, 2026
By:
/s/ Lisa Ricciardi
Name:
Lisa Ricciardi
Title:
President and Chief Executive Officer
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: tm2615260d1_ex99-1.htm · Sequence: 2
Exhibit 99.1
Cognition Therapeutics
Completes Meeting with FDA for
Zervimesine (CT1812) in Dementia with Lewy Bodies with Psychosis
- Positive Discussion
on Path Forward for Registrational Program -
PURCHASE, NY – May 21, 2026
– Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing product
candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), conducted a planned meeting
with the U.S. Food and Drug Administration (FDA) on May 20, 2026. The objective of this meeting was to review results from the Phase
2 study of zervimesine (CT1812) and discuss the design and endpoints of a registrational study in dementia with Lewy bodies (DLB) patients
with psychosis.
Lisa Ricciardi, president and
CEO of Cognition, stated, “Yesterday we held a productive meeting with the FDA. The agency and we discussed the results from our Phase
2 COG1201 ‘SHIMMER’ Study in DLB and our proposed plan to advance zervimesine into a registrational program. We believe we
have a path forward for the development of zervimesine for the treatment of DLB psychosis. We look forward to reviewing the FDA’s
formal minutes in June.”
About Cognition Therapeutics:
Cognition Therapeutics, Inc.
is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating
neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying
mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across
indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s
disease, geographic atrophy, Parkinson’s, among others. The company’s lead candidate, zervimesine (CT1812), is an investigational
once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease.
Backed by nearly $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance
clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden. Learn more at
cogrx.com.
About Zervimesine (CT1812)
Zervimesine (CT1812) is currently
being studied in the Phase 2 START Study (NCT05531656) in patients with MCI and early Alzheimer’s disease. Phase 2 clinical
studies have concluded in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary
to dry AMD. Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the company
plans to advance zervimesine into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated
in clinical studies to date.
The USAN Council has adopted zervimesine
as the United States Adopted Name (USAN) for CT1812.
Cognition Therapeutics, Inc.
www.cogrx.com
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release
or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions,
including but not limited to, statements regarding our cash runway, our product candidates, including zervimesine (CT1812), and any expected
or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later
trials and our clinical development plans, including statements regarding our clinical studies of zervimesine, any analyses of the results
therefrom, as well as statements regarding our regulatory plans, are forward-looking statements. These statements, including statements
relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important
factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance,
or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by
terms such as “may,” “might,” “will,” “should,” “expect,” “plan,”
“aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,”
“contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential”
or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements
largely on our current expectations and projections about future events and financial trends that we believe may affect our business,
financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and
are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are
beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited
to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships
with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates
through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results
of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical
trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates;
changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive
factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we
compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our
intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability
to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the
“Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are
available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these
forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements
may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover,
we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible
for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to
publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events,
changed circumstances or otherwise.
Contact Information:
Cognition Therapeutics, Inc.
info@cogrx.com
Mike Moyer (investors)
LifeSci Advisors
mmoyer@lifesciadvisors.com
Cognition Therapeutics, Inc.
www.cogrx.com
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