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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): November 3, 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 2.02 Results of Operations and Financial Condition.
On November 5, 2026,
Cognition Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended
September 30, 2026. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information disclosed under Item 2.02, including Exhibit 99.1,
is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated
by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific
reference in such filing.
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued
Listing Rule or Standard; Transfer of Listing
On November 3, 2026, the Company received a deficiency letter from
the Nasdaq Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying
the Company that, for the last 30 consecutive business days, the closing bid price for the Company’s common stock has been below
the minimum $1.00 per share required for continued listing on Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5450(a)(1) (“Rule
5450(a)(1)”). The Nasdaq deficiency letter has no immediate effect on the listing of the Company’s common stock, and its common
stock will continue to trade on Nasdaq Capital Market under the symbol “CGTX” at this time.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has
been given 180 calendar days, or until May 3, 2027, to regain compliance with Rule 5450(a)(1). If at any time before May 3, 2027, the
bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Staff
will provide written confirmation that the Company has achieved compliance.
If the Company does not regain compliance with Rule 5450(a)(1) by May
3, 2027, the Company may be afforded a second 180 calendar day period to regain compliance. To qualify, the Company would be required
to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq
Capital Market, except for the minimum bid price requirement. In addition, the Company would be required to notify Nasdaq of its intent
to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Staff concludes that
the Company will not be able to cure the deficiency, or if the Company does not regain compliance with the minimum bid price requirement
within such additional 180 calendar day compliance period, the Staff will provide written notification to the Company that the Company’s
common stock will be subject to delisting. At that time, the Company may appeal the Staff’s delisting determination to a Nasdaq
Hearings Panel (“Panel”). However, there can be no assurance that, if the Company receives a delisting notice and appeals
the delisting determination by the Staff to Panel, such appeal would be successful.
The Company intends to actively monitor the closing bid price for its
common stock and will consider available options to resolve the deficiency and regain compliance with Rule 5450(a)(1). However, there
can be no assurance that the Company will be able to regain compliance with the minimum bid price requirement or that the Staff will grant
the Company a further extension of time to regain compliance, if applicable.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits
are being furnished herewith:
Exhibit
No. |
|
Document |
| 99.1 |
|
Press Release, dated November 5, 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: November 5, 2026 |
|
|
| |
By: |
/s/ Lisa Ricciardi |
| |
Name: |
Lisa Ricciardi |
| |
Title: |
President and Chief Executive Officer |
Exhibit 99.1
Cognition Therapeutics Reports Financial Results
for the Third Quarter 2026
and Provides Business Update
- Management conference call at 8:30 a.m. ET
today -
Purchase, NY – November 5, 2026 – Cognition Therapeutics,
Inc. (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders (the “Company”
or “Cognition”), today reported financial results for the third quarter ended September 30, 2026, and provided a business
update.
Lisa Ricciardi, Cognition’s president and CEO stated, “The
work we conducted with the Office of Neuroscience at the FDA during 2026 culminated in the development of a trial protocol for a planned
registrational study of zervimesine (CT1812) in people with dementia with Lewy bodies (DLB). We are now evaluating our plans for manufacturing,
site selection, and patient recruitment.
“At the same time, we are working with our collaborators at
the Alzheimer’s Clinical Trial Consortium (ACTC) to prepare for the conclusion of the Phase 2 START Study in people with MCI and
early Alzheimer’s disease,” Ms. Ricciardi added. “Top-line results from START are anticipated in the second half of
2027 and will inform our plans for zervimesine in Alzheimer’s disease.”
Business and Corporate Highlights
| · | Aligned
with FDA on primary and key secondary endpoints for Phase 3 trial of zervimesine in DLB.
|
| · | Began
development of Phase 3 protocol with insights from panels of people with DLB and caregivers. |
| · | Received
issued patent with natural expiration of 2045 from United States Patent and Trademark Office
(USPTO) covering a novel crystalline form of zervimesine. |
| · | Received
notice that poster developed with Alzheimer’s Clinical Trials Consortium (ACTC) has
been accepted for presentation at Clinical Trials in Alzheimer’s Disease (CTAD) annual
meeting. Presentation highlights efficiencies achieved in Phase 2 START study by using
p-Tau 217 assay during screening. |
Third Quarter 2026 Financial Results
Cash, cash equivalents, and restricted cash equivalents as of September
30, 2026 were approximately $31.5 million, and total obligated grant funds remaining from the National Institute of Aging, a division
of the National Institute of Health were $18.2 million. The Company estimates that it has sufficient cash to fund operations and capital
expenditures into the fourth quarter of 2027.
Research and development expenses were $5.1 million for the quarter
ended September 30, 2026, compared to $3.8 million for the comparable period in 2025. The increase in research and development expenses
was driven by higher trial activities with contract research organizations and professional fees.
General and administrative expenses were $2.3 million for the quarter
ended September 30, 2026, compared to $2.6 million for the comparable period in 2025. The decrease in general and administrative expenses
was driven primarily by lower professional fees and compensation.
The Company reported a net loss of $4.1 million, or $(0.04) per basic
and diluted share for the third quarter ended September 30, 2026, compared to a net loss of $4.9 million, or $(0.06) per basic and diluted
share for the same period in 2025.
Cognition
Therapeutics, Inc.
www.cogrx.com
Conference Call & Webcast Details
| Title: |
Cognition Third Quarter 2026 Financial Results and Business Update |
| Date |
November 5, 2026 |
| Time: |
8:30 AM Eastern Time |
| Dial In: |
Toll Free (US & Canada) 1-800-715-9871 |
| US/International Toll |
1-646-307-1963 |
| Conference ID: |
9023814 |
| Call me™: |
https://registrations.events/easyconnect/9023814/recFvJxj663evg74H/ |
| Webcast: |
https://webcast.ir-events.com/bKXwO501v80 |
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.
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.
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, our cash runway, 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 planned FDA interactions and registrational program for zervimesine, 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.
Cognition
Therapeutics, Inc.
www.cogrx.com
Cognition Therapeutics, Inc.
Unaudited Selected Financial Data
| (in thousands, except share and per share data amounts) | |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| Statements of Operations Data: | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Operating Expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
$ | 5,124 | | |
$ | 3,773 | | |
$ | 16,341 | | |
$ | 26,040 | |
| General and administrative | |
| 2,253 | | |
| 2,602 | | |
| 7,591 | | |
| 8,088 | |
| Total operating expenses | |
| 7,377 | | |
| 6,375 | | |
| 23,932 | | |
| 34,128 | |
| Loss from operations | |
| (7,377 | ) | |
| (6,375 | ) | |
| (23,932 | ) | |
| (34,128 | ) |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Grant income | |
| 2,966 | | |
| 1,215 | | |
| 10,463 | | |
| 13,407 | |
| Other income, net | |
| 267 | | |
| 230 | | |
| 831 | | |
| 585 | |
| Interest expense | |
| (1 | ) | |
| — | | |
| (9 | ) | |
| (8 | ) |
| Total other income, net | |
| 3,232 | | |
| 1,445 | | |
| 11,285 | | |
| 13,984 | |
| Net loss and comprehensive loss | |
$ | (4,145 | ) | |
$ | (4,930 | ) | |
$ | (12,647 | ) | |
$ | (20,144 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss per share: | |
| | | |
| | | |
| | | |
| | |
| Basic | |
$ | (0.04 | ) | |
$ | (0.06 | ) | |
$ | (0.14 | ) | |
$ | (0.30 | ) |
| Diluted | |
$ | (0.04 | ) | |
$ | (0.06 | ) | |
$ | (0.14 | ) | |
$ | (0.30 | ) |
| Weighted-average common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
| Basic | |
| 95,096,095 | | |
| 77,951,513 | | |
| 91,658,892 | | |
| 67,488,145 | |
| Diluted | |
| 95,096,095 | | |
| 77,951,513 | | |
| 91,658,892 | | |
| 67,488,145 | |
| | |
As of | |
| (in thousands) | |
September 30, 2026 | | |
December 31, 2025 | |
| Balance Sheet Data: | |
| | | |
| | |
| Cash, cash equivalents, and restricted cash equivalents | |
$ | 31,475 | | |
$ | 37,000 | |
| Total assets | |
| 34,803 | | |
| 48,390 | |
| Total liabilities | |
| 5,526 | | |
| 14,119 | |
| Accumulated deficit | |
| (211,294 | ) | |
| (198,647 | ) |
| Total stockholders’ equity | |
| 29,277 | | |
| 34,271 | |
Contact Information: Cognition Therapeutics, Inc. info@cogrx.com |
Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com |
Cognition
Therapeutics, Inc.
www.cogrx.com