8-K
COGNITION THERAPEUTICS INC (CGTX)
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): August8, 2024
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 Avenue****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 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:
| Exhibit No. | Document |
|---|---|
| 99.1 | Press Release, dated August 8,<br> 2024 |
| 104 | Cover Page Interactive<br> 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. | |
|---|---|
| By: | /s/<br> Lisa Ricciardi |
| Name: | Lisa Ricciardi |
| Title: | President and Chief Executive Officer |
Date: August 8, 2024
Exhibit 99.1
CognitionTherapeutics Reports Financial Results for the Second Quarter 2024 and Provides Businessand Clinical Update
- Proof-of-ConceptPhase 2 SHINE Trial Demonstrates ~40% Mean Improvement in ADAS-Cog 11 vs Placebo and Consistent Positive Changes Across Multiple Cognitiveand Functional Measures -
- On Track toReport Topline Results from SHIMMER Study in Mild-to-Moderate DLB by YE 2024 -
- Company toHost 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<br> 2 proof-of-concept SHINE study (NCT03507790) of CT1812 in 153 participants with mild-to-moderate<br> Alzheimer’s disease demonstrated consistent positive changes slowing cognitive decline,<br> a biomarker signal of neuroprotection, and a favorable safety and tolerability profile |
|---|---|
| o | Participants<br> treated with once daily oral CT1812 (pooled 100 and 300mg) experienced a 39% slowing of decline<br> compared to placebo-treated as measured with ADAS-Cog 11* |
| --- | --- |
| o | Consistent<br> trends favoring CT1812 were observed in other cognitive measures: ADAS-Cog 13, cognitive<br> composite, MMSE; and in functional measures: ADCS-ADL and ADCS-CGIC |
| --- | --- |
| o | A<br> significant reduction in neurofilament light chain (NfL), a biomarker of neurodegeneration,<br> in participants treated with 300mg CT1812 compared to placebo |
| --- | --- |
| o | No<br> discontinuations due to AEs in the 100mg CT1812 group; all elevated liver enzymes occurring<br> in the 300 mg dose group; serious adverse events (SAE) similar in placebo and treated arms |
| --- | --- |
| o | Results<br> presented at the 2024 Alzheimer’s Association International Conference (AAIC) |
| --- | --- |
| · | Investor<br> webcast held to discuss SHINE results, an archive of which is available here. |
| --- | --- |
| · | Published<br> three manuscripts that demonstrate CT1812 impact on pathways related to amyloid biology,<br> synapse and neuroinflammation, hallmarks of Alzheimer’s disease pathology: |
| --- | --- |
| o | Proteomic<br> analyses from the first cohort of the Phase 2 COG0201 ‘SHINE’ study (SHINE-A)<br> in the journal, Neurobiology of Disease |
| --- | --- |
| o | Clinical<br> 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<br> progress in Phase 2 START study (NCT05531656) of CT1812 in early Alzheimer’s disease |
|---|---|
| · | Continued<br> enrollment in Phase 2 MAGNIFY study (NCT05893537) of CT1812 in geographic atrophy secondary<br> 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,<br> 2024 at 8:30am ET / 5:30am PT |
|---|---|
| Telephone Access: | US/Canada Participant Toll-Free<br> Dial-in Number: (800) 715-9871<br><br> <br>US/Canada Participant International<br> Dial-In Number: (646) 307-1963<br><br> <br>Conference ID Number: 3702003 |
| Webcast Access: | The<br> audio webcast with live Q&A will be accessible at https://edge.media-server.com/mmc/p/3napeebe<br> or via the Investor Relations section of Cognition’s website. An archive of the webcast and presentation will be available<br> for 90 days beginning at approximately 10:30 a.m. ET on August 8, 2024. |
* CT1812 did not achieve statisticalsignificance on ADAS-Cog 11, the first of the ordered secondary efficacy endpoints, in the pooled 100mg and 300mg dose group comparedto 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 releasecontains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements containedin this press release, other than statements of historical facts or statements that relate to present facts or current conditions, areforward-looking statements. These statements, including statements relating to our product candidates, including CT1812, and any expectedor implied benefits or results, including that initial clinical results observed with respect to CT1812 will be replicated in late trialsand 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 knownand unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materiallydifferent 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 financialtrends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speakonly as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot bepredicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from currentexpectations include, but are not limited to: our ability to successfully advance our current and future product candidates through developmentactivities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary dataand pre-clinical studies being predictive of the results of clinical trials; the timing, scope and likelihood of regulatory filings andapprovals, including regulatory approval of our product candidates; competition; our ability to secure new (and retain existing) grantfunding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; changesin 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 intellectualproperty; the impacts of ongoing global and regional conflicts; the impact of the COVID-19 pandemic on our business, supply chain andlabor force; and the risks and uncertainties described in the “Risk Factors” section of our annual and quarterly reportsfiled the Securities & Exchange Commission. These risks are not exhaustive and we face both known and unknown risks. Youshould not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-lookingstatements 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 notpossible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do notplan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, futureevents, changed circumstances or otherwise.
Cognition Therapeutics, Inc.
www.cogrx.com
CognitionTherapeutics, Inc.
Unaudited SelectedFinancial 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:<br><br> <br>Cognition<br> Therapeutics, Inc. <br><br> info@cogrx.com | Casey<br> McDonald (media) <br><br> Tiberend Strategic Advisors, Inc. <br><br> cmcdonald@tiberend.com | Mike Moyer (investors)<br><br> <br>LifeSci Advisors<br><br> <br>mmoyer@lifesciadvisors.com | ||||||||||
| --- | --- | --- |
Cognition Therapeutics, Inc.
www.cogrx.com