# EDGAR Filing Document

**Accession Number:** 0001455365
**File Stem:** 0001104659-26-077060
**Filing Date:** 2026-6
**Character Count:** 15155
**Document Hash:** 1b4cbc808920d8e9248201b17ddc06de
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-26-077060.hdr.sgml**: 20260624

**ACCESSION NUMBER**: 0001104659-26-077060

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20260624

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260624

**DATE AS OF CHANGE**: 20260624

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** COGNITION THERAPEUTICS INC
- **CENTRAL INDEX KEY:** 0001455365
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40886
- **FILM NUMBER:** 261113111

**BUSINESS ADDRESS:**
- **STREET 1:** 2500 WESTCHESTER AVE
- **CITY:** PURCHASE
- **STATE:** NY
- **ZIP:** 10577
- **BUSINESS PHONE:** 412-481-2210

**MAIL ADDRESS:**
- **STREET 1:** 2500 WESTCHESTER AVE
- **CITY:** PURCHASE
- **STATE:** NY
- **ZIP:** 10577

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** COGNITION THERAPUTICS INC
- **DATE OF NAME CHANGE:** 20090204

?xml version='1.0' encoding='ASCII'?

**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): June 24, 2026

**Cognition Therapeutics, Inc.**

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-40886** | **13-4365359** |
| (State or other jurisdiction of<br> incorporation or organization) | (Commission File Number) | (I.R.S. Employer<br> Identification No.) |

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| | |
|:---|:---|
| **2500 Westchester Ave.** **<br> Purchase, NY** | **10577** |
| (Address of principal executive offices) | (Zip Code) |

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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):

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| |
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| 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)) |

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Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **Title of Each Class** | **Trading Symbol** | **Name of Exchange on Which<br> Registered** |
| Common Stock, par value $0.001 per share | CGTX | The Nasdaq Stock Market LLC |

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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 ⌧

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 June 24, 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") following the Company's recent meeting with the FDA in May. 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:

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| | |
|:---|:---|
| **Exhibit<br> No.** | **Document** |
| [99.1](tm2618699d1_ex99-1.htm) | [Press Release, dated June 24, 2026.](tm2618699d1_ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**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.

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| | | |
|:---|:---|:---|
|  | **COGNITION THERAPEUTICS, INC.** | **COGNITION THERAPEUTICS, INC.** |
| Date: June 24, 2026 |  |  |
|  | By: | */s/ Lisa Ricciardi* |
|  | Name: | Lisa Ricciardi |
|  | Title: | President and Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**

![](tm2618699d1_ex99-1img01.jpg)

**Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis Following Receipt of FDA Meeting Minutes** 

*- Zervimesine Would be the First Long-term, Durable Treatment Option with an Impact on Underlying Disease -*

*- Company Developing NPI as a Measure of DLB Psychosis -*

PURCHASE, NY – June 24, 2026 – <u>Cognition Therapeutics, Inc.</u>, (the "Company" or "Cognition") (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, today announced that it received written feedback from the U.S. Food and Drug Administration (FDA) following its recent meeting. The FDA agreed that psychosis associated with dementia with Lewy bodies (DLB) could be an approvable outcome and reached alignment with the Company on key aspects of a pivotal trial to support a New Drug Application (NDA). The registrational program is expected to begin in mid-2027.

As discussed with the FDA, Cognition expects the Phase 3 study will enroll people with DLB who experience psychosis symptoms of hallucinations and delusions. Patients receiving stable background treatment with off-label antipsychotic medications will be eligible. Following screening, participants will be randomized to receive either 100 mg of once-daily oral zervimesine or placebo for nine months. The company will work with the FDA on the analytical and statistical details for the use of the neuropsychiatric inventory (NPI) as a novel primary endpoint for a pivotal trial in DLB psychosis.

"We reached an important agreement with the FDA that DLB psychosis is an approvable outcome and that key aspects of our registrational trial design are appropriate and supportive of an NDA," explained Anthony O. Caggiano, MD, PhD, chief medical officer of Cognition. "To date, few drugs have been researched for DLB and none have been approved. The only recourse for DLB patients experiencing psychosis is the off-label use of potentially dangerous antipsychotics."

The proposed Phase 3 study builds on findings from Cognition's <u>Phase 2 COG1201 'SHIMMER' trial</u> in mild-to-moderate DLB, which demonstrated improvements in psychosis symptoms with zervimesine versus placebo as measured by the NPI. In a recent analysis of results from the Phase 2 study, zervimesine slowed progression of hallucinations and delusions by 89%. In July, the Company will present additional analyses from the Phase 2 study showing zervimesine's impact on the hallucination and delusion components of the NPI at the Alzheimer's Association's International Conference (AAIC).

"Working with the FDA, we intend to find a path forward for a patient population that has waited too long," said <u>Lisa Ricciardi, president and CEO</u>. "Our ultimate goal is to provide patients and their families with a durable treatment option for DLB psychosis that actually slows the progression of hallucinations and delusions."

**About Cognition Therapeutics** 

<u>Cognition Therapeutics, Inc.</u> 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 <u>cogrx.com</u>.

Cognition Therapeutics, Inc.

www.cogrx.com

**About DLB Psychosis**

Dementia with Lewy bodies (DLB) is a progressive, fatal neurodegenerative disease characterized by neuropsychiatric, cognitive and motor deficits. Up to 80% of people living with DLB experience psychosis, which manifests primarily as debilitating hallucinations and delusions. These symptoms are frequently cited as the most challenging for patients and their care partners to manage. There are no FDA-approved drugs for DLB, and the off-label use of traditional antipsychotics is often avoided due to the risk of severe and potentially life-threatening adverse reactions, underscoring a critical unmet need.

**About Zervimesine (CT1812)** 

<u>Zervimesine</u> (CT1812) is currently being studied in the Phase 2 START Study (<u>NCT05531656</u>) 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 (<u>NCT05225415</u>), 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.

**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 plans, are forward-looking statements. These statements, including statements relating to the study design, 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 <u>www.sec.gov</u>. 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.*

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|:---|:---|
| **Contact Information:** <br> Cognition Therapeutics, Inc.<br> <u>info@cogrx.com</u> | Mike Moyer (investors)<br> LifeSci Advisors<br> <u>mmoyer@lifesciadvisors.com</u> |

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Cognition Therapeutics, Inc.

www.cogrx.com