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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): August 6, 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 August 6, 2026, Cognition
Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 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 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits
are being furnished herewith:
Exhibit
No. |
|
Document |
| 99.1 |
|
Press Release, dated August 6, 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: August 6, 2026 |
|
|
| |
By: |
/s/ Lisa Ricciardi |
| |
Name: |
Lisa Ricciardi |
| |
Title: |
President and Chief Executive Officer |
Exhibit 99.1
Cognition Therapeutics Reports Financial Results
for the Second Quarter 2026 and Provides Business Update
Purchase, NY – August 6, 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 second quarter ended June 30, 2026, and provided a business update.
“The second quarter marked important progress across both our
clinical and corporate priorities,” said Lisa Ricciardi, Cognition’s president and CEO. “Discussions with the Food and
Drug Administration (FDA) brought clarity on key aspects of our planned Phase 3 trial for people with dementia with Lewy bodies (DLB)
who experience psychosis (DLB psychosis). We are focused on initiating our Phase 3 study in mid-2027 with an improved tablet composition.
In addition, the allowance of a new composition of matter patent meaningfully extends our intellectual property coverage for zervimesine
and reinforces the long-term value of our pipeline.”
Business and Corporate Highlights
| · | Conducted a planned meeting with the FDA to discuss the design of a registrational
study in DLB psychosis; Company to provide update on timing after alignment on endpoints |
| · | Received
a Notice of Allowance for a patent application covering composition of matter, production
process, and therapeutic method of treating Alzheimer’s disease and DLB with a polymorphic
crystalline form of zervimesine. Once issued, the patent would extend protection through
2045 before patent-term extension |
| · | Extended the ongoing expanded access program for zervimesine in DLB through
2027 with funding from a second philanthropic donor |
| · | Presented
a poster at the Alzheimer’s Association International Convention (AAIC) outlining
a proposed Phase 3 study design for zervimesine in DLB psychosis. |
Second Quarter 2026 Financial Results
Cash, cash equivalents, and restricted cash equivalents as of June
30, 2026 were approximately $34.8 million, and total obligated grant funds remaining from the National Institute of Aging, a division
of the National Institute of Health were $21.6 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 June 30, 2026, compared to $11.5 million for the comparable period in 2025. The decrease in research and development expenses was
driven by lower trial activities with contract research organizations, compensation and professional fees.
General and administrative expenses were $2.6 million for the quarter
ended June 30, 2026, compared to $2.5 million for the comparable period in 2025. The increase in general and administrative expenses was
driven primarily by higher professional fees.
The Company reported a net loss of $3.9 million, or $(0.04) per basic
and diluted share for the second quarter ended June 30, 2026, compared to a net loss of $6.7 million, or $(0.11) per basic and diluted
share for the same period in 2025.
Cognition Therapeutics, Inc.
www.cogrx.com
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 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, the EAP, and any analyses of the
results therefrom, 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 the 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 Global 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 June 30, | | |
Six Months Ended June 30, | |
| Statements of Operations Data: | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Operating Expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
$ | 5,097 | | |
$ | 11,481 | | |
$ | 11,217 | | |
$ | 22,267 | |
| General and administrative | |
| 2,641 | | |
| 2,497 | | |
| 5,338 | | |
| 5,486 | |
| Total operating expenses | |
| 7,738 | | |
| 13,978 | | |
| 16,555 | | |
| 27,753 | |
| Loss from operations | |
| (7,738 | ) | |
| (13,978 | ) | |
| (16,555 | ) | |
| (27,753 | ) |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Grant income | |
| 3,518 | | |
| 7,106 | | |
| 7,497 | | |
| 12,192 | |
| Other income, net | |
| 291 | | |
| 141 | | |
| 564 | | |
| 355 | |
| Interest expense | |
| (3 | ) | |
| (3 | ) | |
| (8 | ) | |
| (8 | ) |
| Total other income, net | |
| 3,806 | | |
| 7,244 | | |
| 8,053 | | |
| 12,539 | |
| Net loss and comprehensive loss | |
$ | (3,932 | ) | |
$ | (6,734 | ) | |
$ | (8,502 | ) | |
$ | (15,214 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss per share: | |
| | | |
| | | |
| | | |
| | |
| Basic | |
$ | (0.04 | ) | |
$ | (0.11 | ) | |
$ | (0.09 | ) | |
$ | (0.24 | ) |
| Diluted | |
$ | (0.04 | ) | |
$ | (0.11 | ) | |
$ | (0.09 | ) | |
$ | (0.24 | ) |
| Weighted-average common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
| Basic | |
| 90,624,381 | | |
| 63,690,945 | | |
| 89,911,806 | | |
| 62,169,748 | |
| Diluted | |
| 90,624,381 | | |
| 63,690,945 | | |
| 89,911,806 | | |
| 62,169,748 | |
| | |
As of | |
| (in thousands) | |
June 30, 2026 | | |
December 31, 2025 | |
| Balance Sheet Data: | |
| | | |
| | |
| Cash, cash equivalents, and restricted cash equivalents | |
$ | 34,762 | | |
$ | 37,000 | |
| Total assets | |
| 38,896 | | |
| 48,390 | |
| Total liabilities | |
| 5,872 | | |
| 14,119 | |
| Accumulated deficit | |
| (207,149 | ) | |
| (198,647 | ) |
| Total stockholders’ equity | |
| 33,024 | | |
| 34,271 | |
Contact Information: Cognition Therapeutics, Inc. info@cogrx.com |
Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com |
Cognition Therapeutics, Inc.
www.cogrx.com