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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): October 22, 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 Results of Operations and Financial Condition.
On October 22,
2026, Cognition Therapeutics, Inc. (the “Company”) issued a press release announcing the receipt of written feedback
from the U.S. Food and Drug Administration (the “FDA”) confirming alignment on key elements of a Phase 3 study in
dementia with Lewy bodies. 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 October 22, 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: October 22, 2026 |
|
|
| |
By: |
/s/ Lisa Ricciardi |
| |
Name: |
Lisa Ricciardi |
| |
Title: |
President and Chief Executive Officer |
Exhibit 99.1
Cognition Therapeutics
Announces Alignment with FDA on Pivotal Phase 3 Trial of Zervimesine (CT1812) in Dementia with Lewy Bodies
PURCHASE, NY – October 22, 2026 – Cognition Therapeutics,
Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative
disorders, has aligned with the U.S. Food and Drug Administration (FDA) on key
elements of a Phase 3 study in dementia with Lewy bodies (DLB) including patient selection, dose, duration, and endpoints. The planned
registrational study is expected to enroll participants with mild-to-moderate DLB who will be randomized to receive either 100 mg of
once-daily oral zervimesine or placebo for nine months.
“Over the course of the year, we have had collaborative discussions
with FDA’s Divisions of Neurology and Psychiatry within the Office of Neuroscience,” stated Lisa Ricciardi, president
and CEO of Cognition. “With FDA’s alignment on trial design, we are completing a protocol to support the planned registrational
study in DLB, a disease with no approved treatments.”
Among DLB’s core diagnostic features, hallucinations are one
of the most measurable symptoms. Cognition’s Phase 3 study will use a neuropsychiatric inventory that measures hallucinations
and delusions (NPI-2) as a primary endpoint. A key secondary endpoint will be the Alzheimer's Disease Cooperative Study – Activities
of Daily Living (ADCS-ADL) scale, which will evaluate zervimesine’s treatment impact on daily function.
“There are currently no blood-based biomarkers to measure how
DLB is progressing, so clinicians evaluate key features to determine how rapidly DLB is progressing,” explained Anthony O. Caggiano,
MD, PhD, Cognition’s CMO. “One such feature is the presence of hallucinations. Hallucinations occur in a majority of
people with DLB, often occur early in disease, and typically worsen as the disease progresses. We believe their presence in early stages
and predictable decline means that changes in psychosis may serve as a proxy for changes in underlying disease.”
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 Dementia with Lewy Bodies (DLB)
Dementia with Lewy bodies (DLB) is a progressive, fatal neurodegenerative
disease characterized by neuropsychiatric, cognitive, and motor deficits. It is the second most common cause of dementia. It is estimated
that 1.4 million Americans are living with DLB. However, research shows that more than half are never diagnosed during their lifetime,
suggesting that the prevalence of DLB could be substantially higher. There are no approved drugs to slow the decline of DLB or treat
the symptoms that are core features of the disease.
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. In the Phase
2 SHIMMER study in DLB (NCT05225415), zervimesine was
shown to slow DLB disease progression, resulting in a slowing of neuropsychiatric, cognitive, motor, and functional symptom progression.
Zervimesine has been generally well tolerated in clinical studies to date.
Cognition Therapeutics, Inc.
www.cogrx.com
Zervimesine is protected by a robust intellectual property portfolio
including a recently issued composition of matter patent covering a novel crystalline form that has a natural expiration of 2045. The
USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812.
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 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 and clinical 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.
Cognition Therapeutics, Inc.
www.cogrx.com
| Contact Information: |
Mike Moyer (investors) |
|
| Cognition Therapeutics, Inc. |
LifeSci Advisors |
|
| info@cogrx.com |
mmoyer@lifesciadvisors.com |
|
Cognition Therapeutics, Inc.
www.cogrx.com
