Slide 1: Cingulate Therapeutics
CINGULATE’ Cingulate Therapeutics Developing next-generation drug candidates where standard-of-care treatments result in suboptimal outcomes September 12, 2022 sp CING-US-111-0923
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than stat
Slide 3: Developing Next-Generation Medications in Billion-Dollar Markets
Developing Next-Generation Medications in Billion-Dollar Markets Immediate Release Film Coat Third Erosion Barrier Release Adderail Layers Single Dose Vyvanse Second Release See the PTR™ Platform in Action *Symphony Data. 12-months rolling through Feb 2022 CINGULATE’ ingles CING-US-111-0923 © 2022 C
Slide 4: Vast Pipeline of Next-Generation Medications Beyond ADHD
Vast Pipeline of Next-Generation Medications Beyond ADHD v Leverage PTR platform faster and with less cost in other therapeutics areas Y Market Criteria: © $1Bnt+ in peak sales O Next-generation mediations with significant improvement over existing therapies Identified PTR™ Platform Pipeline Opportu
Slide 5: FIRST and ONLY ADHD Medication Designed to Overcome All Unmet Needs
FIRST and ONLY ADHD Medication Designed to Overcome All Unmet Needs Precision Timed Release™ (PTR™) Platform Unlocks the Possibility for ‘True’ Once-daily, Multi-dose Tablets $18 Fast Onset Billion’ of Action Eliminate Need for ‘Booster/Recovery’ Meds US ADHD Eliminate Rebound/Crash Market Dominated
Slide 6: Targeting Treatment of ADHD - $18Bn US Market Opportunity
Targeting Treatment of ADHD - $18Bn US Market Opportunity Frequently diagnosed, chronic pattern interfering with functioning / development ~17 Million US ADHD Patients ocietal Impact of ADHD Estimated annual incremental costs of $143 to $266 billion in the United States Adult ADHD Children & Adolesc
Slide 7: $18 Billion US ADHD Market Dominated by Stimulants
$18 Billion US ADHD Market Dominated by Stimulants Stimulants 91% of US Market $15.3Bn2 Y 1QVIA Survey of ADHD market found over 60% of providers were currently \ unsatisfied with available treatment \ options? Methylphenidates Amphetamines = Ritalin® / LA = Vyvanse® = Concerta® Adderall® / XR Y De-
Slide 8: ADHD Market Currently Dominated by Stimulant Products
ADHD Market Currently Dominated by 4 Stimulant Products Major Unmet Medical Needs Persist DHD BRAN RIBUTES? MET NEEDS? Fast Onset of Duration Action Entire Active- Minimize (less onset) < 30min Day Efficacy* Crash/Rebound Avoid Booster? Vyvanse® 2007 2 hours 12 hours x x ee x Adderall® XR 2001 1%hou
Slide 9: ADHD Market Leaders Do Not Provide “Built-In Booster”
ADHD Market Leaders Do Not Provide “Built-In Booster” Market Leaders Stop Delivery of Medication 4-5 Hours After Administration ADHD A . BRANDS ATTRIBUTES RELEASE PROFILES: Durati (less onset) DOSE 1 / STYLE / TIME DOSE 2 / STYLE / TIME DOSE 3 / STYLE /TIME 100% PRODRUG Vyvanse® 2 hours 12 hours SUS
Slide 10: Recent Launches Lack Meaningful Clinical Innovation
Recent Launches Lack Meaningful Clinical Innovation Quillivant / Chew? XR Mydayis® Adzenys® ER/ODT Cotempla® XR/ODT Aptensio® XR Evekeo® / ODT Dynavel® XR Oral Susp. Zenzedi® Jornay® PM (at night) Adhansia® XR Azstarys® (summer 2021) om Cl INGULATE" Niche Delivery Platforms — Designed to Fail in ADH
Slide 11: The Cingulate Solution for ADHD
The Cingulate Solution for ADHD Patients & Providers 4 YEEMASTERY’ YSACCOMPLISH® CTx-1301 CTx-1302 CING-US-111-0923
Slide 12: Nine Significant Points of Differentiation
Nine Significant Points of Differentiation NO ADHD product available today combines all unmet needs Vv Provide ‘entire active-day’ efficacy v Fast onset of action v Eliminate need for booster/recovery dose v Avoid crash and rebound effect PTR™ technology affords our product candidates the following
Slide 13: CTx-1301 (d-MPH) and CTx-1302 (d-AMP)
CTx-1301 (d-MPH) and CTx-1302 (d-AMP) IGULATE TARGET ATTRIBUTES RELEASE PROFILES CTx-1301 e a 45% SUSTAINED RELEASE OVER 90 MINUTES AT 20% IMMEDIATE RELEASE (4-MPH) 30 mins Up to 16 hours 35% IMMEDIATE RELEASE HOUR 3 ATHOUR7 CTx-1302 A 2) 35% SUSTAINED RELEASE OVER 90 MINUTES AT 20% IMMEDIATE RELEAS
Slide 14: CTx-1301 Clinical Phase Study Results
CTx-1301 Clinical Phase 2 Study Results Plasma dexmethylphenidate (dMMPH) Concentration vs Time Extends duration for ‘entire active-day’ without the Low Dose booster dose! 3000 Results demonstrate fast onset with the desired Fast Onset controlled descent 2500 Minimize ‘crash/rebound’ effect, common
Slide 15: At the Individual Level, Tri-modal Delivery is Clear
At the Individual Level, Tri-modal Delivery is Clear Entire Active-Day Efficacy, Stop the Crash & Rebound, Eliminate the Booster Dose Subject ID: 01-504 —® CTx-1301 6.25-mg —®— Focalin XR 5-mg —® CTx-1301 50-mg —®— Focalin XR 40-mg os Subject ID: 01-510 —® CTx-1301 6.25-mg —®— Focalin XR 5-mg —®— CT
Slide 16: CTx-1301 Demonstrated Significantly Lower Adverse Events
CTx-1301 Demonstrated Significantly Lower Adverse Events 28.6% reduction in TEAE’s related to CTx-1301 versus Focalin XR (14.3% difference) Focalin XR 5 CTx-1301 6.25 Focalin XR 40 CTx-1301 All All mg mg (n=39) mg (n=43) 50 mg (n=42) CTx-1301 Focalin XR (n=41) (n=42) (n=44) Treatment Emergent Advers
Slide 17: CTx-1301 Clinical and Regulatory Timeline
MASTERY © CTx-1301 Clinical and Regulatory Timeline 2022 2023 2024 CLINICAL PHASE 3b Adult Dose- Optimization Efficacy and Safety Study to Evaluate Onset and Duration N~100 Exploratory Endpoints Target dates; actual timeline may vary NDA Preparation and Filing CINGULATE’ ingulate.com CING-US-111-092
Slide 18: Commercialization to Drive Revenue
Commercialization to Drive Revenue Changing dynamics in ADHD commercial Maximize Access for Patients and Providers landscape Clinical, Practical, and Societal Story: Ability to dominate share of voice Efficacy and Tolerability o Concerta, Adderall XR, Focalin XR are all off- patent with no promotion
Slide 19: Exclusivity: IP, Agreements, and Trade Secrets
Exclusivity: IP, Agreements, and Trade Secrets Intellectual property rights expected to provide exclusivity through 2035 at a minimum ° Oralogik™ Erosion Barrier Layer . Five (5) patents granted (US & Global) expiry dates ranging from 2031 to 2035, ° One (1) Oralogik™ patent pending (US, Europe) ° T
Slide 20: Cingulate Mission
Cingulate Mission Develop... Shape market acceptance, and... Prepare to commercialize next-generation drug candidates... Where currently prescribed standard-of-care treatments result in suboptimal outcomes for all stakeholders Achievement Drives Shareholder and Team Member Value CINGULATE’ Gingulate
Slide 21: Thank You
CINGULATE’ Thank You