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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
8, 2024
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 Avenue
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 8, 2024, Cognition Therapeutics, Inc. (the “Company”)
issued a press release announcing its financial results for the quarter ended June 30, 2024. 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:
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. |
|
|
|
By: |
/s/
Lisa Ricciardi |
|
Name: |
Lisa Ricciardi |
|
Title: |
President and Chief Executive Officer |
|
Date: August 8, 2024
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1455365/000110465924087001/tm2421054d1_ex99-1img002.jpg)
Cognition
Therapeutics Reports Financial Results for the Second Quarter 2024 and Provides Business
and Clinical Update
- Proof-of-Concept
Phase 2 SHINE Trial Demonstrates ~40% Mean Improvement in ADAS-Cog 11 vs Placebo and Consistent Positive Changes Across Multiple Cognitive
and Functional Measures -
- On Track to
Report Topline Results from SHIMMER Study in Mild-to-Moderate DLB by YE 2024 -
- Company to
Host Investor Conference Call at 8:30 a.m. -
Purchase,
NY – August 8, 2024 – 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, 2024, and provided a business update.
“We
announced favorable results from the Phase 2 ‘SHINE’ Study that provided proof-of-concept that CT1812 has potential to slow
the progression of mild-to-moderate Alzheimer’s disease after just six months of treatment,” said Lisa
Ricciardi, Cognition’s president and CEO. “In terms of next steps, we are looking forward to reading out results from our
‘SHIMMER’ study in mild-to-moderate dementia with Lewy bodies by year-end 2024 and are now planning the next phase of development
in our Alzheimer's disease program.”
Business and Corporate Highlights
| · | Phase
2 proof-of-concept SHINE study (NCT03507790) of CT1812 in 153 participants with mild-to-moderate
Alzheimer’s disease demonstrated consistent positive changes slowing cognitive decline,
a biomarker signal of neuroprotection, and a favorable safety and tolerability profile |
| o | Participants
treated with once daily oral CT1812 (pooled 100 and 300mg) experienced a 39% slowing of decline
compared to placebo-treated as measured with ADAS-Cog 11* |
| o | Consistent
trends favoring CT1812 were observed in other cognitive measures: ADAS-Cog 13, cognitive
composite, MMSE; and in functional measures: ADCS-ADL and ADCS-CGIC |
| o | A
significant reduction in neurofilament light chain (NfL), a biomarker of neurodegeneration,
in participants treated with 300mg CT1812 compared to placebo |
| o | No
discontinuations due to AEs in the 100mg CT1812 group; all elevated liver enzymes occurring
in the 300 mg dose group; serious adverse events (SAE) similar in placebo and treated arms |
| o | Results
presented at the 2024 Alzheimer’s Association International Conference (AAIC) |
| · | Investor
webcast held to discuss SHINE results, an archive of which is available here. |
| · | Published
three manuscripts that demonstrate CT1812 impact on pathways related to amyloid biology,
synapse and neuroinflammation, hallmarks of Alzheimer’s disease pathology: |
| o | Proteomic
analyses from the first cohort of the Phase 2 COG0201 ‘SHINE’ study (SHINE-A)
in the journal, Neurobiology of Disease |
| o | Clinical
findings from the Phase 1b COG0105 ‘SPARC’ study in Alzheimer's Research &
Therapy and the Phase 2 COG0202 ‘SEQUEL’ study in The Journal of Prevention
of Alzheimer's Disease |
Cognition
Therapeutics, Inc.
www.cogrx.com
| · | Continued
progress in Phase 2 START study (NCT05531656) of CT1812 in early Alzheimer’s disease |
| · | Continued
enrollment in Phase 2 MAGNIFY study (NCT05893537) of CT1812 in geographic atrophy secondary
to dry age-related macular degeneration |
Second Quarter 2024 Financial Results
Cash
and cash equivalents as of June 30, 2024 were approximately $28.5 million and total grant funds remaining from the NIA were $57.3
million. The Company estimates that it has sufficient cash to fund operations and capital expenditures
into the second quarter of 2025.
Research and development expenses were
$11.6 million for the second quarter ended June 30, 2024, compared to $8.5 million for the comparable period in 2023. The increase
was primarily related to higher costs associated with advancing our clinical programs, including Phase 2 trial activities with contract
research organizations and personnel cost.
General and administrative expenses
were $3.1 million for the second quarter ended June 30, 2024, compared to $3.3 million for the comparable period in 2023. The decrease
was primarily related to lower professional services.
The Company reported a net loss of $7.0
million, or $(0.18) per basic and diluted share for the second quarter ended June 30, 2024, compared to a net loss of $4.7 million,
or $(0.16) per basic and diluted share for the same period in 2023.
Conference Call
Date
/ Time |
August 8,
2024 at 8:30am ET / 5:30am PT |
|
|
Telephone
Access: |
US/Canada Participant Toll-Free
Dial-in Number: (800) 715-9871
US/Canada Participant International
Dial-In Number: (646) 307-1963
Conference ID Number: 3702003 |
|
|
Webcast
Access: |
The
audio webcast with live Q&A will be accessible at https://edge.media-server.com/mmc/p/3napeebe
or via the Investor Relations section of Cognition’s website. An archive of the webcast and presentation will be available
for 90 days beginning at approximately 10:30 a.m. ET on August 8, 2024. |
* CT1812 did not achieve statistical
significance on ADAS-Cog 11, the first of the ordered secondary efficacy endpoints, in the pooled 100mg and 300mg dose group compared
to placebo
About Cognition Therapeutics:
Cognition
Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule
therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our
lead candidate CT1812 in clinical programs in Alzheimer’s
disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2
receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with
CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative
diseases. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com/.
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, other than statements of historical facts or statements that relate to present facts or current conditions, are
forward-looking statements. These statements, including statements relating to our product candidates, including CT1812, and any expected
or implied benefits or results, including that initial clinical results observed with respect to CT1812 will be replicated in late trials
and our clinical development plans, including statements regarding our clinical studies of CT1812 and any analyses of the results therefrom,
the timing and expected results of our clinical trials, upcoming presentations on our clinical trials, and cash runway, 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: 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
and pre-clinical studies being predictive of the results of clinical trials; the timing, scope and likelihood of regulatory filings and
approvals, including regulatory approval of our product candidates; 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; 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; the impact of the COVID-19 pandemic on our business, supply chain and
labor force; and the risks and uncertainties described in the “Risk Factors” section of our annual and quarterly reports
filed the Securities & Exchange Commission. 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, | |
Consolidated Statements of Operations Data: | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating Expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 11,577 | | |
$ | 8,497 | | |
$ | 22,130 | | |
$ | 13,927 | |
General and administrative | |
| 3,101 | | |
| 3,320 | | |
| 6,650 | | |
| 6,863 | |
Total operating expenses | |
| 14,678 | | |
| 11,817 | | |
| 28,780 | | |
| 20,790 | |
Loss from operations | |
| (14,678 | ) | |
| (11,817 | ) | |
| (28,780 | ) | |
| (20,790 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Grant income | |
| 7,311 | | |
| 6,925 | | |
| 12,223 | | |
| 10,351 | |
Other income (expense), net | |
| 333 | | |
| 172 | | |
| 577 | | |
| (443 | ) |
Interest expense | |
| (7 | ) | |
| (6 | ) | |
| (17 | ) | |
| (16 | ) |
Loss on currency translation from liquidation of subsidiary | |
| — | | |
| — | | |
| (195 | ) | |
| — | |
Total other income, net | |
| 7,637 | | |
| 7,091 | | |
| 12,588 | | |
| 9,892 | |
Net loss | |
$ | (7,041 | ) | |
$ | (4,726 | ) | |
$ | (16,192 | ) | |
$ | (10,898 | ) |
Foreign currency translation adjustment, including reclassifications | |
| — | | |
| (1 | ) | |
| 195 | | |
| 3 | |
Total comprehensive loss | |
$ | (7,041 | ) | |
$ | (4,727 | ) | |
$ | (15,997 | ) | |
$ | (10,895 | ) |
Net loss per share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (0.18 | ) | |
$ | (0.16 | ) | |
$ | (0.44 | ) | |
$ | (0.37 | ) |
Diluted | |
$ | (0.18 | ) | |
$ | (0.16 | ) | |
$ | (0.44 | ) | |
$ | (0.37 | ) |
Weighted-average common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 40,062,954 | | |
| 29,614,822 | | |
| 36,899,112 | | |
| 29,356,144 | |
Diluted | |
| 40,062,954 | | |
| 29,614,822 | | |
| 36,899,112 | | |
| 29,356,144 | |
| |
As of | |
(in thousands) | |
June 30, 2024 | | |
December 31, 2023 | |
Consolidated Balance Sheet Data: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 28,533 | | |
$ | 29,922 | |
Total assets | |
| 34,369 | | |
| 35,163 | |
Total liabilities | |
| 11,360 | | |
| 10,689 | |
Accumulated deficit | |
| (157,381 | ) | |
| (141,189 | ) |
Total stockholders’ equity | |
| 23,009 | | |
| 24,474 | |
Contact Information:
Cognition
Therapeutics, Inc.
info@cogrx.com |
Casey
McDonald (media)
Tiberend Strategic Advisors, Inc.
cmcdonald@tiberend.com |
Mike Moyer (investors)
LifeSci Advisors
mmoyer@lifesciadvisors.com |
Cognition
Therapeutics, Inc.
www.cogrx.com
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