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8-K

Cognition Therapeutics Inc (CGTX)

8-K 2026-05-21 For: 2026-05-21
View Original
Added on May 21, 2026

UNITED

STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549

FORM 8-K

CURRENT REPORTPursuant 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<br> or other jurisdiction of<br><br> incorporation or organization) (Commission File Number) (I.R.S.<br> Employer<br><br> Identification No.)
**2500 Westchester Ave.**Purchase , NY 10577
--- ---
(Address<br> of principal executive offices) (Zip<br> 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement<br> 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<br> Stock, par value $0.001 per share CGTX The<br> 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:

ExhibitNo. 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

Exhibit 99.1

Cognition TherapeuticsCompletes Meeting with FDA for

Zervimesine (CT1812) in Dementia with Lewy Bodies with Psychosis

- Positive Discussionon 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-lookingstatements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press releaseor 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 expectedor implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in latertrials and our clinical development plans, including statements regarding our clinical studies of zervimesine, any analyses of the resultstherefrom, as well as statements regarding our regulatory plans, are forward-looking statements. These statements, including statementsrelating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other importantfactors 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 byterms 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 statementslargely 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 andare subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which arebeyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limitedto: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationshipswith suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidatesthrough development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the resultsof preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinicaltrials; 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 competitivefactors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which wecompete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend ourintellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our abilityto 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 areavailable at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on theseforward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statementsmay 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 possiblefor management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan topublicly 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:<br><br> <br>****<br><br> <br>Cognition Therapeutics, Inc.<br><br> info@cogrx.com Mike Moyer (investors)<br><br> <br>LifeSci Advisors<br><br> <br>mmoyer@lifesciadvisors.com
Cognition Therapeutics, Inc.

www.cogrx.com