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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): May 7, 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 May 7, 2026, Cognition
Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31,
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 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits
are being furnished herewith:
Exhibit
No. |
|
Document |
| 99.1 |
|
Press Release, dated May 7, 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 7, 2026 |
|
|
| |
By: |
/s/ Lisa Ricciardi |
| |
Name: |
Lisa Ricciardi |
| |
Title: |
President and Chief Executive Officer |
Exhibit 99.1
Cognition Therapeutics Reports Financial
Results for the First Quarter 2026
and Provides Business Update
Meeting with FDA Division of Psychiatry
scheduled for May 2026 expected to inform
registrational plans for zervimesine in DLB psychosis
Purchase, NY – May 7, 2026 –
Cognition Therapeutics, Inc. (NASDAQ: CGTX), clinical-stage company developing product candidates that treat neurodegenerative
disorders, (the “Company” or “Cognition”), today reported financial results for the first quarter ended March
31, 2026, and provided a business update.
“We filed a request to meet with the Food
and Drug Administration’s Division of Psychiatry to discuss our plans for a registrational study in people with dementia with Lewy
body (DLB) psychosis,” stated Lisa Ricciardi, Cognition’s president and CEO. “We recently received our meeting
invitation for May 20, 2026 and we are looking forward to a productive conversation so we can continue to move zervimesine forward in
this important indication.
“Looking ahead, we remain committed to developing zervimesine
for the treatment of Alzheimer’s disease. Topline results from the 545-participant Phase 2 ‘START’ COG0203 (NCT05531656)
study in mild cognitive impairment (MCI) and early Alzheimer's disease are anticipated in 2027. We expect these findings will inform our
clinical development plans for Alzheimer’s disease.”
Business and Corporate Highlights
| · | Requested a meeting with FDA Division of Psychiatry,
which is expected to be conducted on May 20 with receipt of meeting minutes anticipated in June. |
| · | Presented
two posters at the AD/PD™ 2026 Alzheimer’s & Parkinson’s Diseases
Conference: |
| o | an
analysis of zervimesine’s effect on the components of the neuropsychiatric index, which was used in the Phase 2 COG1201 SHIMMER
study (NCT05225415) in participants with DLB; and |
| o | a
proposed composite endpoint containing measures of memory, motor, fluctuations, behavior and psychosis,
which may be an effective method of capturing the complexity of DLB symptoms in future clinical trials. |
First Quarter 2025 Financial Results
Cash, cash equivalents, and restricted cash equivalents as of March
31, 2026 were approximately $31.2 million, and total obligated grant funds remaining from the National Institute of Aging, a division
of the National Institute of Health were $25.6 million. The Company estimates that it has sufficient cash to fund operations and capital
expenditures through the second quarter of 2027.
Research and development expenses were $6.1 million for the quarter
ended March 31, 2026, compared to $10.8 million for the comparable period in 2025. The decrease in research and development expenses was
driven by lower trial activities with contract research organizations and professional fees.
General and administrative expenses were $2.7 million for the quarter
ended March 31, 2026, compared to $3.0 million for the comparable period in 2025. The decrease in general and administrative expenses
was driven primarily by lower stock compensation, compensation and professional fees.
Cognition Therapeutics, Inc.
www.cogrx.com
The Company reported a net loss of $4.6 million, or $(0.05) per
basic and diluted share for the first quarter ended March 31, 2026, compared to a net loss of $8.5 million, or $(0.14) per basic and diluted
share for the same period in 2025.
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
been completed 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.
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 cash runway, 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 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 March 31, | |
| Consolidated Statements of Operations Data: | |
2026 | | |
2025 | |
| Operating Expenses: | |
| | | |
| | |
| Research and development | |
$ | 6,120 | | |
$ | 10,786 | |
| General and administrative | |
| 2,697 | | |
| 2,989 | |
| Total operating expenses | |
| 8,817 | | |
| 13,775 | |
| Loss from operations | |
| (8,817 | ) | |
| (13,775 | ) |
| Other income (expense): | |
| | | |
| | |
| Grant income | |
| 3,979 | | |
| 5,086 | |
| Other income, net | |
| 273 | | |
| 214 | |
| Interest expense | |
| (5 | ) | |
| (5 | ) |
| Total other income, net | |
| 4,247 | | |
| 5,295 | |
| Net loss and comprehensive loss | |
$ | (4,570 | ) | |
$ | (8,480 | ) |
| | |
| | | |
| | |
| Net loss per share: | |
| | | |
| | |
| Basic | |
$ | (0.05 | ) | |
$ | (0.14 | ) |
| Diluted | |
$ | (0.05 | ) | |
$ | (0.14 | ) |
| Weighted-average common shares outstanding: | |
| | | |
| | |
| Basic | |
| 89,191,313 | | |
| 61,828,149 | |
| Diluted | |
| 89,191,313 | | |
| 61,828,149 | |
| | |
As of | |
| (in thousands) | |
March 31,
2026 | | |
December 31,
2025 | |
| Consolidated Balance Sheet Data: | |
| | | |
| | |
| Cash, cash equivalents, and restricted cash equivalents | |
$ | 31,225 | | |
$ | 37,000 | |
| Total assets | |
| 36,140 | | |
| 48,390 | |
| Total liabilities | |
| 6,229 | | |
| 14,119 | |
| Accumulated deficit | |
| (203,217 | ) | |
| (198,647 | ) |
| Total stockholders’ equity | |
| 29,911 | | |
| 34,271 | |
| | |
| | | |
| | |
|
Contact Information:
Cognition Therapeutics, Inc.
info@cogrx.com |
Mike Moyer (investors)
LifeSci Advisors
mmoyer@lifesciadvisors.com |
Cognition Therapeutics, Inc.
www.cogrx.com