Form 8-K

8-K — COGNITION THERAPEUTICS INC

Accession: 0001104659-26-117948

Filed: 2026-10-22

Period: 2026-10-22

CIK: 0001455365

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2628101d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2628101d1_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):  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,

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

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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2628101d1_ex99-1.htm · Sequence: 2

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

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