corporate overview cingulatetherapeuticsisaprivately-held ... · patrick gallagher director arthur...

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RAPID MILESTONE ACHIEVEMENT 2017-2018 ü Camargo retained ü Pre-IND activities 2019 – 2Q 2020 ü IND Package Submissions ü Phase 1 and 2 Trials 3Q 2020 - 2021 ü Phase 3 Trials ü NDA Prep & Submission 2022 ü Approvals ü Launches CTx-1301 Development Timeline CORPORATE OVERVIEW INVESTMENT HIGHLIGHTS The Platform PTR™ Platform has potential to fully disrupt the oral drug delivery market Technology applicable across multiple indications, 12+ future drugs targeted for evaluation Lead Indication Initial focus on $15B+ ADHD market with two lead candidates, offers multiple shots on goal Drug candidates designed to address the major unmet needs of the ADHD patients– with advantages demonstrated via two successful human trials; Phase 2 pivotal bioavailability study ongoing Accelerated development timeline, working with approved chemical entities Funding Raised ~$26M to date. Company will raise an additional $75 million to bring ADHD assets to approval Current offering of preferred equity units Team Experienced management team with proven development and commercialization expertise Established, world class scientific advisory board with recognized thought leaders Cingulate Therapeutics is a privately-held, clinical-stage biopharmaceutical company focused on the development of new and innovative medications utilizing the Company’s disruptive, proprietary Precision Timed Release™ (PTR™) drug delivery platform that allows for the creation of a true once-daily, multi-dose tablet. The Company is currently raising up to $25 million to complete Phase II and to initiate Phase III human trials for the first of two drugs in development exclusively designed to overcome the unmet medical needs of ADHD patients, a $15 billion market. By using previously approved drugs with the PTR™ platform, Cingulate will pursue FDA approval via the 505(B)(2) pathway, with market availability and meaningful ROI in as few as 24 months. Lead Assets Driving Growth: CTx-1301 & CTx-1302 FOR ADHD NO ADHD product available today combines all unmet needs: ü Lasts the entire active-day (duration) ü Rapid onset (works fast) ü Controlled descent of drug levels to minimize or avoid crash/rebound effect ü Eliminate need for afternoon booster/recovery dose ü Preferred Access / Affordability 60% of patients use short-acting ‘booster’ dose every day! © 2020 Cingulate Therapeutics

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Page 1: CORPORATE OVERVIEW CingulateTherapeuticsisaprivately-held ... · Patrick Gallagher Director Arthur Straughn Director In Summary •Experienced management team & advisors •Initial

RAPID MILESTONE ACHIEVEMENT

2017-2018

üCamargo retained

üPre-IND activities

2019 – 2Q 2020

ü IND Package Submissions

üPhase 1 and 2 Trials

3Q 2020 - 2021

üPhase 3 Trials

üNDA Prep & Submission

2022

üApprovals

ü Launches

CTx-1301 Development Timeline

CORPORATE OVERVIEW

INVESTMENT HIGHLIGHTS

The Platform • PTR™ Platform has potential to fully disrupt the oral drug delivery market• Technology applicable across multiple indications, 12+ future drugs targeted for evaluation

Lead Indication• Initial focus on $15B+ ADHD market with two lead candidates, offers multiple shots on goal• Drug candidates designed to address the major unmet needs of the ADHD patients– with advantages

demonstrated via two successful human trials; Phase 2 pivotal bioavailability study ongoing• Accelerated development timeline, working with approved chemical entities

Funding • Raised ~$26M to date. Company will raise an additional $75 million to bring ADHD assets to approval• Current offering of preferred equity units

Team • Experienced management team with proven development and commercialization expertise• Established, world class scientific advisory board with recognized thought leaders

Cingulate Therapeutics is a privately-held, clinical-stage biopharmaceutical company focused on thedevelopment of new and innovative medications utilizing the Company’s disruptive, proprietary Precision TimedRelease™ (PTR™) drug delivery platform that allows for the creation of a true once-daily, multi-dose tablet.The Company is currently raising up to $25 million to complete Phase II and to initiate Phase III human trials forthe first of two drugs in development exclusively designed to overcome the unmet medical needs of ADHDpatients, a $15 billion market.By using previously approved drugs with the PTR™ platform, Cingulate will pursue FDA approval via the 505(B)(2) pathway, with market availability and meaningful ROI in as few as 24 months.

Lead Assets Driving Growth: CTx-1301 & CTx-1302 FOR ADHDNO ADHD product available today combines all unmet needs:

ü Lasts the entire active-day (duration)ü Rapid onset (works fast)ü Controlled descent of drug levels to minimize or avoid

crash/rebound effect ü Eliminate need for afternoon booster/recovery doseü Preferred Access / Affordability

60% of patients use short-acting ‘booster’ dose

every day!

© 2020 Cingulate Therapeutics

Page 2: CORPORATE OVERVIEW CingulateTherapeuticsisaprivately-held ... · Patrick Gallagher Director Arthur Straughn Director In Summary •Experienced management team & advisors •Initial

Precision Timed ReleaseTM Drug Delivery Platform

Multi-core tablet capabilities

Semi-continuous manufacturing with real-time release

Maximum efficiency for COGs sold

Applicability across multiple therapeutic areas

• Proprietary Erosion Barrier Layer (EBL)• Specialized compression technology• Semi-continuous manufacturing with real-time release

Triad of proprietary, sophisticated elements

• Ability to create tablets with up to 5 drug combinations • Ideal drug delivery where unmet need exists across dozens of therapeutic areas• Maximum efficiency for cost of goods sold (COGs)• Manufacture ⇨ Package ⇨ Ship

Specialized, Disruptive Manufacturing Process achieves:

• CNS Disorders, Cardiovascular Disease, Diabetes, Pain & others• Licensing options exist, in addition to future in-house assets

ADHD assets in development. Future assets identified in:

• Patent protection from erosion barrier, multi-modal drug release, including drug delivery manner, timing, and ratio

• Manufacturing trade secrets and exclusivity agreements

Exclusivity via:

CONTACTS:CorporateRyan [email protected](816) 304-0292

Investor RelationsTiberend Strategic Advisors, Inc.Miriam Weber [email protected](212) 375-2694

®

MANAGEMENT TEAM

Shane J. Schaffer, PharmD Chief Executive Officer, Co-Founder

Lou Van Horn, MBA, CPAChief Financial Officer

Laurie A. Myers, PhD, MBAChief Operating Officer

Raul Silva, MDChief Scientific Officer, Co-Founder

Matthew Brams, MD Chief Medical Officer, Co-Founder

Craig S. Gilgallon, EsqGeneral Counsel

BOARD OF DIRECTORS

Shane J. Schaffer Chairman

Peter J. WerthDirector

Jeff HargrovesDirector

Matthew BramsDirector

Jeff ConroyDirector

Patrick GallagherDirector

Arthur StraughnDirector

In Summary• Experienced management team & advisors

• Initial two assets in $15B+ ADHD market

• Strong pipeline capability via PTR ™

• CTx-1301 was granted an active IND, 3Q19; Phase 2 Pivotal Trial underway

• CTx-1302 will initiate clinical trials in 3Q20

CAPITAL RAISE STRATEGY2014 - 2018

$8MClosed

$11MClosed

Foundational Preferred Classes

2Q 2020

ØSeries AØCrossoverØ IPO

$50-60M

2019-1Q 2020Up to $25M

($7M+ Closed)Open

CTx® ACHIEVES OPTIMAL ONCE-DAILY DOSE

© 2020 Cingulate Therapeutics