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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): December 18, 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)
  (Primary Standard Industrial
Classification Code 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 8.01 Other Events.

 

Cognition Therapeutics, Inc. (the “Company”) has made available a slide presentation relating to the topline data from its Phase 2 COG1201 SHIMMER study, a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibits are being furnished herewith:

 

Exhibit
No.
  Document
99.1   Corporate presentation of Cognition Therapeutics, Inc.
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: December 18, 2024    
  By: /s/ Lisa Ricciardi
  Name: Lisa Ricciardi
  Title: President and Chief Executive Officer

 

 

 

Exhibit 99.1

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1 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this presentation, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, 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 later trials, and our clinical development plans, the timing of any regulatory submissions, and expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, including statements regarding our clinical studies of CT1812 in animal models and any analyses of the results therefrom, are forward-looking statements. These statements, including statements related 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 presentation 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, preclinical 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; 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; 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 more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission that are available on 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. TRADEMARKS This presentation may contain trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this presentation may be listed without the TM, SM © or ® symbols, but we will assert, to the fullest extent under applicable law, the rights of the applicable owners, if any, to these trademarks, service marks, trade names and copyrights. MARKET & INDUSTRY DATA Projections, estimates, industry data and information contained in this presentation, including the size of and growth in key end markets, are based on information from third-party sources and management estimates. Although we believe that these third party-sources are reliable, we cannot guarantee the accuracy or completeness of these sources. Our management’s estimates are derived from third-party sources, publicly available information, our knowledge of our industry and assumptions based on such information and knowledge. Our management’s estimates have not been verified by any independent source. All of the projections, estimates, market data and industry information used in this presentation involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such information. In addition, projections, estimates and assumptions relating to us and our industry's future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including, but not limited to, those described above, that could cause future performance to differ materially from our expressed projections, estimates and assumptions or those provided by third parties. Forward-looking Statements

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Topline Results Phase 2 Study of CT1812 in Mild-to-Moderate Dementia with Lewy Bodies December 18, 2024

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Director of the Comprehensive Center for Brain Health University of Miami Miller School of Medicine Director at Large of the LBDA Board of Directors and member of the Scientific Advisory Council James E. Galvin, MD, MPH

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4 • 2nd most common cause of dementia after Alzheimer’s disease • Characterized by cognitive impairment that precedes development of motor symptoms • More common in men • Patients may have faster decline than Alzheimer’s • Patients often require several physician visits over 18 months before being correctly diagnosed Dementia with Lewy Bodies (DLB) Core Symptoms of DLB: • Fluctuating cognition and alertness • Neuropsychiatric symptoms such as visual hallucinations, anxiety, depression and delusions • Decline in cognition, attention, executive function • Spontaneous parkinsonism • REM sleep behavior disorder

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5 “A multifactorial disease with a buffet of symptoms” Four Symptom Domains Drive Lewy Body Disease Burden Behavior Cognition Function Movement Patient symptom hallucinations, anxiety, delusions Memory and problem solving Bathing, toileting, shopping, meal preparation Standing, maintaining balance Assessment tool Neuropsychiatric Inventory (NPI) Care Partner’s NPI of “Distress” Cognitive Drug Research (CDR) System Montreal Cognitive Assessment (MoCA) Clinician Assessment of Fluctuation (CAF) ADCS-Activities of Daily Living (ADL) MDS-Unified Parkinson’s Disease Rating Scale (UPDRS)

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6 SHIMMER Study Designed to Assess Multifactorial Burden Conducted in Collaboration with LBDA Centers of Excellence, Academic Centers and Industry SHIMMER COG1201 study (NCT05225415) partially funded by $30M NIA grant R01AG071643 Key Enrollment Criteria Treatment Period 6 months Assessments Study Objectives ‐ Age 50-85 ‐ DLB diagnosis ‐ MRI ‐ MMSE: 18-27 ‐ Safety/tolerability ‐ Behavior: ‐ NPI ‐ Cognition ‐ MoCA, CDR, CAF ‐ Function: ‐ ADCS-ADL ‐ Motor ‐ UPDRS III ‐ Epworth Sleep ‐ Global CGIC ‐ Biomarkers  Confirm safety and tolerability profile  Explore impact on behavior, movement, cognition and function  Identify dose(s) for Phase 3 Placebo CT1812 100 mg CT1812 300 mg Oral QD Administration Randomized 1:1:1 130 participants randomized from 31 sites across U.S. including LBDA centers of excellence DLB, Dementia with Lewy Bodies; MMSE, Mini-Mental State Examination; MRI, magnetic resonance imaging; QD, daily; NIA, National Institute on Aging; LBDA, Lewy Body Dementia Association; ADCS-CGIC, Clinicians Global Impression of Change

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7 Up to 91% Percent Slowing on Assessments Strong clinical signals across major DLB symptoms relative to placebo * Measure of the distress experienced by the care partners of SHIMMER participants Behavior Cognition Function Movement NPI (total) NPI (distress) CDR (episodic memory) MoCA CAF ADCS-ADL UPDRS CT1812 Pooled (100/300mg) 82% 114%* 85% 60% 91% 52% 62%

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8 CT1812 Showed Dramatic 82% Impact on Neuropsychiatric Measures NPI captures a variety of patient disturbances, including hallucinations, anxiety, and delusions -4 -2 0 2 4 6 0 NPI Total (ITT) CT1812 Pooled Placebo Baseline Day 28 Day 98 Day 182 worsening NPI favor Treatment with CT1812 LS Mean Difference from Placebo 95% CI Favors CT1812 82% slowing Anxiety Delusions Hallucinations Agitation/Aggression Depression Sleep Behavior Appetite Irritability Disinhibition Aberrant Motor Elation/Euphoria Apathy -3 -2 -1 0 1 2 NPI: Neuropsychiatric inventory

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9 worsening Because Participants Improved in Hallucinations, Delusions & Anxiety, Caregivers were Notably Better New tool created to measure caregiver burden in DLB -2 -1.5 -1 -0.5 0 0.5 1 1.5 2 2.5 3 0 NPI (Distress) ITT CT1812 Pooled Placebo Baseline Day 28 Day 98 Day 182 114% slowing NPI Distress favors Treatment with CT1812 LS Mean Difference from Placebo 95% CI Anxiety Delusions Hallucinations Agitation/Aggression Depression Sleep Behavior Appetite Irritability Disinhibition Aberrant Motor Elation/Euphoria Apathy Favors CT1812 -1.5 -1 -0.5 0 0.5 1 NPI Distress: Neuropsychiatric inventory (Care Partner Distress)

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10 Up to 91% Slowing of Cognitive Decline Across Assessments CT1812 improved patients’ attentiveness and problem solving -1 -0.8 -0.6 -0.4 -0.2 0 0.2 0 MoCA (ITT) Baseline Day 28 Day 98 Day 182 -1 -0.5 0 0.5 1 1.5 0 CAF (fluctuations) (ITT) Baseline Day 28 Day 98 Day 182 -15 -10 -5 0 5 0 CDR - Episodic Memory (ITT) CT1812 Pooled Placebo Baseline Day 28 Day 98 Day 182 85% slowing 60% slowing 91% slowing worsening CDR: Cognitive Drug Research (CDR) Battery; MoCA: Montreal Cognitive Assessment; CAF: Clinician Assessment of Fluctuation

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11 Components of ADL Score 52% preservation in activities of daily living (ADL) measures People on CT1812 Maintained Self-care -10 -8 -6 -4 -2 0 2 0 ADCS-ADL (ITT) CT1812 Pooled Placebo Baseline Day 28 Day 98 Day 182 52% slowing worsening • Bathing • Dressing • Grooming • Feeding • Toileting • Conversing • Shopping • Writing ADCS-ADL: Activities of Daily Living

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12 Components of UPDRS: 62% preservation in measures of movement People Treated with CT1812 Maintained Motor Function -2 -1 0 1 2 3 4 5 6 0 MDS-UPDRS Part III (ITT) CT1812 Pooled Placebo Baseline Day 28 Day 98 Day 182 62% slowing worsening • Balance • Speech • Rigidity • Tremor • Gait • Timed up and go • Facial expression MDS-UPDRS: Unified Parkinson’s Disease Rating Scale

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13 Behavior, Cognition, Movement, Function all Improved with CT1812 Oral once-daily therapy has potential to change the course of disease for patients and families -1 -0.5 0 0.5 1 1.5 0 CAF (fluctuations) Baseline Day 28 Day 98 Day 182 -1 -0.8 -0.6 -0.4 -0.2 0 0.2 0 MoCA Baseline Day 28 Day 98 Day 182 -10 -8 -6 -4 -2 0 2 0 ADCS-ADL Baseline Day 28 Day 98 Day 182 -2 -1 0 1 2 3 0 NPI (Care Partner Distress) Baseline Day 28 Day 98 Day 182 -2 0 2 4 6 0 MDS-UPDRS Part III Baseline Day 28 Day 98 Day 182 0.0 0.3 0.5 0.8 1.0 0 ADCS-CGIC Baseline Day 28 Day 98 Day 182 -15 -10 -5 0 0 Episodic Memory Baseline Day 28 Day 98 Day 182 CT1812 (pooled) Placebo -4 -2 0 2 4 6 0 NPI Total Baseline Day 28 Day 98 Day 182

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Anthony O Caggiano, MD, PhD Study Conduct, Disposition and Safety

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15 • Limited physician and site knowledge, experience in DLB • Supported by $30M grant from NIA - R01AG071643 • Conducted at 34 sites in the United States - 14 - LBDA Centers of Excellence - 7 - Academic - 13 - Industry sites • First patient in (FPI): March 2022 (slow start emerging from covid) • Last patient out (LPO): November 2024 • Oversight by Data Safety Monitoring Board (DSMB) Collectively overcame enrollment hurdles due to COVID-19 lag and limited DLB awareness Partnership with LBDA, academic and industry leaders led to successful trial execution

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16 Participant Disposition Analysis populations • ITT : 44 • Safety : 43 293 Screened 130 Randomized 44 Randomized to 100mg CT1812 44 Randomized to 300mg CT1812 42 Randomized to placebo Analysis populations • ITT: 44 • Safety: 44 Analysis populations • ITT : 42 • Safety : 42 33 Completed study 11 Discontinued Tx • 9 (20.5%) DC due to AE • 2 (4.6%) Withdrawal 40 Completed study 4 Discontinued Tx • 4 (9.1%) DC due to AE 36 Completed study 8 Discontinued Tx • 5 (11.9%) DC due to AE • 3 (7.1%) Withdrawal

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17 Pooled CT1812 (n=88) Placebo (n=42) Total (n=130) Age – years* 72.3 (6.89) 73.7 (6.25) 72.8 (6.69) Gender: % Male 83.0 78.6 81.5 Race: % White 92.0 90.5 91.5 Non-Hispanic or Latino % 98.9 92.9 96.9 MMSE* 24.1 (2.65) 23.8 (2.69) 24.0 (2.66) MoCA* 18.7 (4.96) 17.9 (4.62) 18.4 (4.85) CAF* 5.3 (3.62) 4.2 (3.41) 5.0 (3.58) ESS* 8.5 (4.25) 8.2 (5.24) 8.4 (4.57) MDS-UPDRS III* 27.3 (13.51) 28.1 (13.41) 27.6 (13.43) ADCS-ADL* 61.7 (11.62) 63.3 (9.77) 62.2 (11.04) Well balanced between treatment and placebo arms Patient Characteristics Consistent with Typical DLB Population *Means (SD)

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18 Favorable safety and tolerability profile COG1201 (SHIMMER): Safety Summary The SAE that was related to IP was for subject 125-0003 (CT1812 300mg). The Preferred Term was ‘Metabolic encephalopathy’. Severity was moderate, drug was interrupted, it was rated as “probably related”, and the outcome was recovered/resolved. It emerged on Day 120 and ended on Day 190. Subjects with: CT1812 Placebo (N=42) Total (N=129) 100 mg (N=44) 300 mg (N=43) At least one TEAE 42 (95.5%) 40 (93.0%) 37 (88.1%) 119 (92.2%) At least one TEAE related to treatment 14 (31.8%) 21 (48.8%) 16 (38.1%) 51 (39.5%) At least one TEAE leading to discontinuation of treatment 4 (9.1%) 9 (20.9%) 5 (11.9%) 18 (14.0%) At least one TEAE leading to discontinuation of study 4 (9.1%) 9 (20.9%) 2 (4.8%) 15 (11.6%) AEs leading to death 0 2 (4.7%) 1 (2.4%) 3 (2.3%) At least one SAE 4 (9.1%) 5 (11.6%) 8 (19.0%) 17 (13.2%) At least one SAE related to treatment 0 1 (2.3%) 0 1 (0.8%) AE of Special Interest: LFTs ≥ 3x ULN (AST or ALT) 3 (6.8%) 6 (14.0%) 0 9 (7.0%) AE Severity - subjects with: Mild 25 (56.8%) 14 (32.6%) 15 (35.7%) 54 (41.9%) Moderate 16 (36.4%) 22 (51.2%) 17 (40.5%) 55 (42.6%) Severe 1 (2.3%) 4 (9.3%) 5 (11.9%) 10 (7.8%) AST: aspartate aminotransferase; ALT: alanine transaminase

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19 Most Common Treatment-Emergent Adverse Events (TEAEs) Nature and severity of adverse event (AE) profile is similar to prior CT1812 trials TEAEs by Preferred Term occurring in 5% of the total safety population, or those in at least 10% of CT1812 treated participants and at least twice the rate of placebo Preferred Term n (%) CT1812 Placebo (N=42) Total (N=129) 100 mg (N=44) 300 mg (N=43) Fall 7 (15.9%) 14 (32.6%) 10 (23.8%) 31 (24.0%) Headache 4 (9.1%) 7 (16.3%) 8 (19.0%) 19 (14.7%) Lipase increase 5 (11.4%) 7 (16.3%) 6 (14.3%) 18 (14.0%) Urinary tract infection 3 (6.8%) 3 (7.0%) 8 (19.0%) 14 (10.9%) Dizziness 3 (6.8%) 4 (9.3%) 5 (11.9%) 12 (9.3%) COVID-19 3 (6.8%) 5 (11.6%) 3 (7.1%) 11 (8.5%) Diarrhoea 4 (9.1%) 5 (11.6%) 2 (4.8%) 11 (8.5%) Fatigue 4 (9.1%) 4 (9.3%) 3 (7.1%) 11 (8.5%) ALT Increase 3 (6.8%) 7 (16.3%) 0 10 (7.8%) Constipation 2 (4.5%) 4 (9.3%) 4 (9.5%) 10 (7.8%) Anxiety 3 (6.8%) 3 (7.0%) 3 (7.1%) 9 (7.0%) AST Increase 4 (9.1%) 5 (11.6%) 0 9 (7.0%) Confustional state 1 (2.3%) 5 (11.6%) 3 (7.1%) 9 (7.0%) Abdominal discomfort 1 (2.3%) 5 (11.6%) 0 6 (4.7%)

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20 • Total AE frequency was similar in CT1812 and placebo • Most AEs were mild or moderate • Fewer Serious AE occurred in the CT1812 treated group compared to placebo treated • There were no deaths related to study drug • Study Discontinuations due to AEs not related to LFTs: - Placebo – 4.8% - 100mg CT1812 – 4.5% - 300 mg CT1812 – 9.3% • Participants with LFT elevations ≥ 3x ULN - 100mg CT1812 – 3 - 300mg CT1812 – 6 - Placebo – 0 • Most common AEs* (other than increased LFTs) in the CT1812 group were diarrhea and abdominal discomfort Favorable safety profile vs placebo, AEs well balanced between arms Summary of SHIMMER Safety and Tolerability findings Adverse Events CT1812 Placebo 94.3% 88.1% Serious AEs CT1812 Placebo 10.3% 19.0% Deaths† CT1812 Placebo 2 1 † not considered treatment related * occurring in a CT1812 treatment group at a rate >10% and at a rate >2X the placebo rate

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21 Planning a Path Forward in Neurological Disease • Podium presentation at ILBDC – January 2025 • Convene advisors to provide protocol input • Engage with regulatory experts • Conduct commercial research • Prepare for end-of-Phase 2 meetings

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22 • COG1201 SHIMMER was a phase 2a safety and tolerability study seeking signals of efficacy in people with dementia with Lewy bodies • The safety and tolerability profile was similar to past experience with CT182 • Clear signals of efficacy were observed - Across Behavioral, Cognitive, Functional and Motor domains - Treatment differences increased over 6 months • These data provide support for advancement of CT1812 as a treatment for dementia with Lewy bodies Identified consistent signals of efficacy and a safe and tolerable dose range SHIMMER Met and Exceeded Objectives and Expectations

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23 • Most importantly – each study participant and their care partners • University of Miami and Dr. James Galvin • NIH and NIA for providing funding • Site investigators and personnel • Our collaborators with the Lewy Body Dementia Association • Cognition colleagues and our CRO partners Cognition Therapeutics is grateful to everyone involved in the COG1201 SHIMMER Trial Acknowledgements

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24 • COG1201 SHIMMER was a phase 2a safety and tolerability study seeking signals of efficacy in people with dementia with Lewy bodies • The safety and tolerability profile was similar to past experience with CT182 • Clear signals of efficacy were observed - Across Behavioral, Cognitive, Functional and Motor domains - Treatment differences increased over 6 months • These data provide support for advancement of CT1812 as a treatment for dementia with Lewy bodies Identified consistent signals of efficacy and a safe and tolerable dose range SHIMMER Met and Exceeded Objectives and Expectations

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