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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
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