Cingulate Inc. · NASDAQ:CING
Cingulate — Investor Presentation (January 2023)
21 slides from Cingulate's investor presentation, Jan 9, 2023
Slide 1: Cingulate Therapeutics
Cingulate Therapeutics Developing next-generation therapeutics where standard-of-care treatments result in suboptimal outcomes OQ - 2023 y 1 i y ! —/ CING-US-118-0124
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: Next-Generation Medications in Billion-Dollar Markets
Next-Generation Medications in Billion-Dollar Markets Precision Timed Release™ (PTR™) Platform Unlocks the Possibility for ‘True’ Once-daily, Multi-dose Tablets Immediate Release Film Coat Third Erosion Barrier Release Layers Second Release See the PTR™ Platform in Action *Symphony Data. 12-months r
Slide 4: Pipeline of Next-Generation Medications in Billion-Dollar Markets
INGULATE’ Insomnia Depression Bipolar Disorder Parkinson's Disease Cardiovascular Disorders Xerostomia (dry mouth) © 2023 Cingulate Inc. Pipeline of Next-Generation Medications in Billion-Dollar Markets Migraine Hypothyroidism Oral Oncology Medicines Psychosis Alzheimer's Disease Pain (Non-Opioid)
Slide 5: Market Dynamics in ADHD & Anxiety
Market Dynamics in ADHD & Anxiety ADHD Anxiety * $18Bn US market * $5Bn US market * Stimulants dominate (90%+) * Buspirone is #1 non-benzodiazepine * Top 4ADHD meds generic at CING launch treatment * PBM rebates going away * Potential for breakthrough approval * Cingulate will dominate Share of Voic
Slide 6: Catalysts Into 2023
Catalysts Into 2023 ADHD CTx-1301 CTx-1302 Anxiety CTx-2103 PTR™ Platform CINGULATE" Sccsreoi 1Q 2023 2Q 2023 2H 2023 Formulation Study Report Food Effect Clinical Study Report > Onset / Efficacy Trial Complete CTx-1301 ; CTx-1301 Adult Onset / Duration Data Pivotal Phase 3 Efficacy Trial > Initiate
Slide 7: FIRST and ONLY ADHD Medication to Overcome All Unmet Needs
FIRST and ONLY ADHD Medication to Overcome All Unmet Needs Precision Timed Release™ (PTR™) Platform Unlocks the Possibility for ‘True’ Once-daily, Multi-dose Tablets $ 1 8 Fast Onset Billion’ of Action US ADHD Eliminate Eliminate Need for ‘Booster/Recovery’ Meds Avoid ‘Wear-off’ Market Rebound/Crash
Slide 8: 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 11M Adults & 6M Children/Adolescents Societal Impact of ADHD Stimulants 91% of US Market $15.3Bn! Million Press ns per Year" Methylph
Slide 9: ADHD Market Currently Dominated by Stimulant Products
ADHD Market Currently Dominated by 4 Stimulant Products Major Unmet Medical Needs Persist ADHD 1 , RANES ATTRIBUTES UNMET NEEDS Fast Onset of Duration Action Entire Active- Minimize Onset (less onset) < 30min Day Efficacy* Crash/Rebound | Avoid Booster? Vyvanse® 2007 2hours 12 hours x x Data Not x A
Slide 10: Recent Launches Lack Meaningful Clinical Innovation
Recent Launches Lack Meaningful Clinical Innovation Niche Delivery Platforms — Designed to Fail in ADHD ADHD BRANDS ATTRIBUTES! UNMET NEEDS a ee ee Product 30 Day Efficae: Booster Quillivant / Chew® XR 60 mins 8 hours x x Mydayis® 2or 4hrs 16+ hours x x x Potentially Adzenys® ER/ODT 60 mins 8-9 hour
Slide 11: The Cingulate Solution for ADHD Patients & Providers
The Cingulate Solution for ADHD Patients & Providers MEMASTERY” YACCOMPLISH® CTx-1301 CTx-1302 CING-US-118-0124
Slide 12: Nine Significant Points of Differentiation
Nine Significant Points of Differentiation NO ADHD product available today combines all unmet needs. PTR™ technology affords our product candidates the following potential advantages over currently available ADHD treatments: Provide ‘Entire Active-Day’ Efficacy Fast onset of action Eliminate need fo
Slide 13: One Product Overcomes All Unmet Needs
One Product Overcomes All Unmet Needs Entire Active-Day Efficacy, Stop the Crash & Rebound, Eliminate the Booster Dose 7am Noon 3pm 0 5 10 15 20 500 TARGET ATTRIBUTES [ee Tee] CTx-1301 (d-MPH) CTx-1301 (4-AMP) 30 mins 6.25-mg 12.5-mg 18.75-mg 25-mg 31.25-mg “CINGULATE 30 mins Up to 16 hours Up to 16
Slide 14: 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 CTx-1301 Focalin XR CTx-1301 All All 5 mg 6.25 mg 40 mg 50mg CTx-1301 Focalin XR (n=41) (n=39) (n=43) (n=42) (n=42) (n=44) Treatment Emergent Adverse
Slide 15: CTx-1301 Clinical and Regulatory Timeline
MASTERY ® CTx-1301 Clinical and Regulatory Timeline 2023 2022 2024 CLINICAL PHASE 3 Adult Dose- PHASE 3 Optimization Pediatric / Adolescent PHASE 4 Efficacy and Safety Study to Evaluate Onset and Duration n~20 Fixed-Dose, Placebo- Controlled Study n=312 Clinical Program Exploratory NDA Approval ~1H
Slide 16: Commercialization to Drive Revenue
Commercialization to Drive Revenue Changing dynamics in ADHD Maximize Access for Patients and Providers commercial landscape * — Clinical, Practical, and Societal Story: * — Ability to dominate share of voice + Efficacy and Tolerability o Concerta, Adderall XR, Focalin XR are all * One versus Two Pr
Slide 17: The Cingulate Solution for Anxiety Patients & Providers
The Cingulate Solution for Anxiety Patients & Providers CING-US-118-0124
Slide 18: CTx-2103 — Buspirone HCl for the Treatment of Anxiety
CTx-2103 — Buspirone HCl for the Treatment of Anxiety Next-Generation Buspirone designed to Improve Patient Outcomes CTx-2103 Trimodal Tablet Single Dose Buspirone 10 mg- Immediate Release Cmax. 1.74 hrs Tmax. 0.71 hrs 1.40 AUC24 3.26 ng-hr/ml =? D100 080 060 oxo 020 00 4 ° s 10 hours 20 3s 30 Treat
Slide 19: Exclusivity: IP, Agreements, and Trade Secrets
Exclusivity: IP, Agreements, and Trade Secrets &Y . Compression technology exclusivity for branded Cingulate products 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
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:
Slide 21: Thank You
‘CINGULATE’ Thank You