Form 8-K - Current report

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): September 12, 2023

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 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 8.01 Other Events.

Attached as Exhibit 99.1 is a presentation that the Company may use from time to time in presentations or discussions with investors, analysts, and other parties.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

The following exhibits are being furnished herewith:

Exhibit No.		Document
99.1		Investor 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: September 12, 2023
	By:	/s/ Lisa Ricciardi
	Name:	Lisa Ricciardi
	Title:	President and Chief Executive Officer

Exhibit 99.1

Disease - modifying medicines for neurodegenerative disorders September 9, 2023

2 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 prese nt that relate to present facts or current conditions, including but not limited to, statements regarding our cash, financial re sou rces and product candidates, including CT1812, and any expected or implied benefits or results, including that initial clinical results that initial clinical results observed with respect to CT1812 will be replicated in later trials, our clinical development pl ans , are forward - looking statements. These statements, including statements related to the timing and expected results of our clini cal trials, results of our clinical trials, involve known and unknown risks, uncertainties and other important factors that may cause our ac tual results, performance, or achievements to be materially different from any future results, performance, or achievements performance, or achievements expressed or implied by the forward - looking statements. In some cases, you can identify forward - loo king statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential ” o r “continue” or the negative of these terms or other similar expressions. We have based these forward - looking statements largely on our our current expectations and projections about future events and financial trends that we believe may affect our business, fi nan cial condition, and results of operations. These forward - looking statements speak only as of the date of this presentation and a re subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of whic h a re 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 gr owt h, 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 relat ed 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, inclu ding regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we ma y b e adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expense s a nd 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 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” sec ti on of our annual and quarterly reports filed with the SEC that are available on www.sec.gov. You should not rely on these forwar d - l ooking 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 a ppl icable 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 propert y o f 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 u nde r 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 en d 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 de rived 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 proje cti ons, 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 assu mpt ions relating to us and our industry's future performance are necessarily subject to a high degree of uncertainty and risk du e t o a variety of factors, including, but not limited to, those described above, that could cause future performance to differ mat eri ally from our expressed projections, estimates and assumptions or those provided by third parties. Forward - looking Statements

3 The people • 2021 ~ 6.5M Americans • 2060 ~ 12.7M Americans The Cost • 2020 – Estimated 11M family members/unpaid caregivers provided 15.3B hours of care at a value of ~$257B* • 2050 – Anticipated caregiving costs ~ $1.1 trillion (in 2019 dollars) ** Alzheimer's Disease (AD) – It impacts every one of us * https://pubmed.ncbi.nlm.nih.gov/33756057/ ** https://www.brightfocus.org/alzheimers/article/alzheimers - disease - facts - figure s

4 • 2 approved mAbs , 1 additional drug filed for approval - Annual cost for therapy = $26K - $28K/ patient - Estimated $5B cost to Medicare for 216K patients on Leqembi • Diagnostics & treatment considerations - 3,600 Infusion centers in the US - 2,500 PET scanners in the US performing 2M scans/year - 11,900 MRI systems in the US • The mismatch between demographics, economics and drug availability is unsustainable AD – Finally breakthroughs & the realities of constraints * https://hitconsultant.net/2022/12/14/report - the - state - of - cancer - centers - 2022/

5 • Why we do what we do : Neurodegenerative diseases, particularly Alzheimer’s disease, impacts every one of us. • How we address neurodegenerative diseases: We identify neurodegeneration targets and treatments. NIH and Advocacy groups help us cost - effectively develop clinical candidates. • What we offer: CT1812 is a potential oral therapy for Alzheimer’s disease and Dementia with Lewy Bodies. We are evaluating clinical, regulatory and biomarkers programs to assess speed to market • Changing the paradigm: Oral drug for the treatment of dry AMD; proven ability to get to the back of the eye Cognition Therapeutics – Our Company

6 CGTX Near - term Catalysts Alzheimer's Development DLB Development GA / Dry AMD Development 2021 2022 2023 2024 2025 Ph2 SHINE (COG0201) Mild - Mod AD Ph2 START (COG0203) Early AD Ph2 SEQUEL (COG0202) qEEG Ph2 SHIMMER (COG1201) DLB Ph2 MAGNIFY (COG2201) GA Topline SHINE Topline SHIMMER Topline IND clearance Protocol clearance SHINE / SPARC Biomarker Data LPI LPI COMPLETE RECRUITING ENROLLING

Our approach to neurodegenerative diseases

8 • Oral, small molecule ligand of sigma - 2 ( σ - 2) receptor - High degree of blood brain barrier penetration, reaches therapeutic target • Targets oligomers, a pathogenic form of amyloid plaques produced early in AD • Blocks toxic oligomer binding, displaces bound oligomers - protecting synapses - Demonstrated disease - modifying impact on synapses • Scalable manufacturing from easily sourced materials, well protected IP Innovative mechanism of action within the established amyloid cascade CT1812 Protects Neurons from Toxic Stressors Represents potential breakthrough: Treat Alzheimer’s disease with a once daily oral drug, minimize imaging requirements and associated side effects

9 Anti - oligomer Mab A β monomer CT1812: A Novel Approach Within the Established Amyloid Cascade Anti - protofibril Mab Anti - plaque Mab CT1812: Protect Synapses • Small molecule ligand to the σ - 2 receptor • Displaces A β oligomers and prevents their binding to synapses mABs : Lower A β plaque • Monoclonal antibodies bind to A β proteins • Immunotherapeutic vaccines generate immune response to A β proteins A β oligomer CT1812 Small Molecule σ - 2 receptor complex TMEM97 PGRMC1

10 • Robust scientific research has demonstrated target engagement and biological effects of σ - 2 modulation • Backed by in vitro studies, behavioral data from in vivo animal models and strong preclinical program • Now in multiple Phase 2 trials • Science vetted through peer - reviewed publications and peer - reviewed NIA grant process σ - 2 is a druggable receptor target CT1812 Designed to Protect Neurons and Processes Impaired in Neurodegenerative Disease

11 Our MoA Video: https://vimeo.com/800999561

Our Trials and Target Product Profile

13 What We Have Learned From Clinical Trials to Date Target engagement Anatomical effect Preliminary cognitive improvement Neurophysiology SEQUEL 3 SHINE - A SPARC 2 SNAP 1 1 1. AD/PD Œ 2022 & LaBarbera, et al. Transl Neurodegener 2023 2. SPARC results submitted for publication 3. Abstract of SEQUEL imaging results submitted for upcoming presentation CT1812 demonstrated target engagement Demonstrated effect on slowing brain atrophy Demonstrated 3+ point difference in cognition measured by ADAS - COG ay Day 185 Brain wave patterns normalized across multiple measures Endpoint of Interest: Result:

14 • SHINE interim analysis (n=24) yields promising evidence: - 3 - point difference (ADAS - COG 11) between treated and untreated participants at Day 185 - Clinically meaningful magnitude of change - Trend towards slower cognitive decline in CT1812 - treated vs placebo - treated participants Clinical Evidence of Cognitive Benefit Cognitive Outcome SHINE COG0201 Study (NCT03507790) funded by NIA grant R01AG058660

15 Phase 2 Study Adults with Mild - to - Moderate DLB -- " The most common dementia you have never heard of " Conducted in collaboration with Lewy Body Dementia Association & U Miami Principal investigator: James E. Galvin, MD, MPH, professor of neurology and director of the Comprehensive Center for Brain H eal th SHIMMER COG1201 study (NCT05225415) partially funded by $30M NIA grant R01AG071643 Enrollment Criteria Treatment Period (6 mo ) Assessments - DLB diagnosis - MRI - EEG - MMSE: 18 - 27 - Safety - Cognitive and functional testing - Biomarkers Placebo (n=40) CT1812 100 mg (n=40) CT1812 300 mg (n=40) 1:1:1 Oral QD Administration

16 Phase 2 Efficacy Study in 540 Adults with Early Alzheimer’s Disease Conducted in collaboration with Alzheimer’s Clinical Trials Consortium Screening Treatment Period (18 mo ) Assessments - Labs - MRI - Brain amyloid via PET - Cognitive testing - Biomarkers (CSF/Plasma) 1:1:1 CT1812 100 mg (n=180) Placebo (n=180) CT1812 200 mg (n=180) Oral QD Administration START COG0203 study (NCT05531656) partially funded by $81M NIA grant R01AG065248 ACTC funded by NIA grant U24AG057437 First study to collect data on combination use of CT1812 and antibody drugs

17 CT1812 – Target profile • Once - daily oral therapy • Slows cognitive and functional decline in early/MCI and mild - to - moderate AD including Dementia with Lewy Bodies • Well tolerated, modest side effect profile for use in aging population - Limited potential for ARIA • Minimal caregiver burden and costs - Routine diagnostics and monitoring requirements - No imaging requirements; reduced associated economics Addresses patient care and caregiver needs and economic burden of treatment Our Goal: Develop & Launch Commercially Successful Dementia Drug Suited to the Realities of US Healthcare System, Patients and Families

18 Gaps in development - stage candidates • Breadth of Indication: AD spectrum including early, MCI, mild and moderate AD and DLB • Limited diagnostic exclusions • Comparable efficacy as measured by ADAS - COG or CDR - SB • No requirement for PET surveillance • No ARIA or infusion safety considerations • Convenience QD dosing, limited monitoring Successful drugs will address gaps in the market New Mechanisms Being Developed, Creating Potential Market for Combination Use 0 25 50 75 100 125 150 Compound MoA 143 Drugs in Development in 2022 (119 are disease modifying) Other Anti - tau Anti - A β MAb Small molecule - Metabolic - Anti - inflammatory - Neuroprotective - Oxidative stress - Gut - Brain axis - Proteostasis - Autophagy - Neurogenesis - Growth factors

19 • Enrollment appx 700 - 1,500 / study • Global enrollment - Randomized 2:1 to CT1812 or placebo - Phase 2 results inform duration • Stratification with concomitant therapy • Initiate heath economics and outcomes research, pricing research and IRA considerations • Baseline - unbiased analyses of plasma/CSF samples: - Phase 1/2 - SHINE Cohort A - SPARC - SHINE A / SPARC pooled - SEQUEL • Identified biomarkers of CT1812 target engagement • Analyzed SHINE, SHIMMER clinical data to determine correlation of biomarkers with cognitive outcomes • Now, evaluate prospective study to assess predetermined biomarkers measuring impact on synapse health, neuroinflammation and A β biology Robust SNAP, SHINE, SPARC and SEQUEL to drive program design Getting to Goal: Phase 2 Program Informs Phase 3 & Regulatory Strategy Preliminary Phase 3 Considerations Preliminary Biomarker Strategy Considerations

20 $0 $10 $20 $30 $40 $50 $60 $70 $80 $90 $100 2016 2017 2018 2019 2020 2021 2022 $15 $7 $17 $3 $81 $45 $2 $3 $5 $55 $42 FY Ending Cash Balance Grant Funding Full Grant Awards by year of Award, significantly support operations Grant Funding Has Provided Substantial Support

Financial Position Financials as of June 30, 2023 • Cash and Cash Equivalents: $37.2 million • Expected cash runway through third quarter of 2024 Grant funding for CT1812 studies as of June 30, 2023 • Preclinical through Phase 2: appx $171.0 million − Approximate funding used: ($89.2 million) − Remaining grant funding: $81.8 million

22 • Complete dementia trials: mild - moderate Alzheimer’s and DLB • Progress START study in early Alzheimer’s disease • Conduct KOL panels on dementia product profile for Phase 3 development • Advance MAGNIFY study in dry AMD • Initiate research on IRA & pricing impact • Continue pharma engagement Next Steps: Preparations for Phase 3 & Commercialization Mild - to - moderate dementia trials to read out in mid 2024

Thank You Tony Caggiano, MD, PhD CMO and Head of R&D 914 - 221 - 6730 acaggiano@cogrx.com Lisa Ricciardi President & CEO 917 - 658 - 5789 lricciardi@cogrx.com John Doyle Chief Financial Officer 914 - 556 - 3347 jdoyle @cogrx.com

Cover	Sep. 12, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 12, 2023
Entity File Number	001-40886
Entity Registrant Name	Cognition Therapeutics, Inc.
Entity Central Index Key	0001455365
Entity Tax Identification Number	13-4365359
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	2500 Westchester Ave.
Entity Address, City or Town	Purchase
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10577
City Area Code	412
Local Phone Number	481-2210
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	CGTX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false