personalized medicine and digital health - automated
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PERSONALIZED MEDICINE
AND DIGITAL HEALTH - AUTOMATED
Panaceutics Rx LLCA Panacea BioMatx Inc Subsidiary6 Davis Drive, Research Triangle Park, NC 27709
Edison Hudson, CEOehudson@panaceutics.com
Personalized Medicine Powered by Technology and Compounding Pharmacy
• Personalized Medicine automation platform based on 503A/ 503B regulatory foundation
• Patented robotic cGMP “Quality by Design” manufacturing system rapidly makes personalized combination therapies on demand from digital script
• Personalized generic combinations to improve adherence via simplified regimen, ease of swallowing, lower costs
• Integration with pharmacogenomic and lab data with decision aids to make right drugs, right dose for patients
Reduced Advese Effects
Individual Efficacy
Higher AdherencePGx Genomics
Lab Assays
Microbiome
Precision ScalableCompounding Automation
IndividualFormulation
PersonalDigital Profile
“N of 1” Combination
Therapy
Low Costs
ImprovedOutcomes
Right Drug, Right Dose, Right Combination at Right Cost
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Applying Emerging Science to Improve Outcomes
Meeting Urgent Patient Need with Personalized Therapies
PRECISION GENERIC COMBINATIONS MADE AT SCALE IN 503A ENVIRONMENT
Integrated healthcare systems value adherence in cost of care
CVD patient populations for both primary and secondary prevention are prime example
Our delivery forms promote adherence through simplification and ease of swallowing in key populations, such as elderly and children
When combined with pharmacogenomic driven clinical decision aids to formulate, can reduce adverse reactions and over/ under dose response
2-3Medications 5-15Medications1-5Supplements
> 50% Adherence
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Personalized Therapies that address “Pill Burden”
So Many Pills, Many Reasons to Stop Taking Them
Hospitals & Integrated Healthcare Systems Have Large Financial Incentives to Address Adherence
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CardioVascular and Metabolic Disease Applications of Panaceutics Rx
https://www.nytimes.com/2019/08/22/health/heart-disease-iran-study.html
Vanderbilt study using PolyPill Ltd Formulation Underserved population in rural Alabama Pill was offered at $1 / day Outcomes were substantial population risk reduction
https://pubmed.ncbi.nlm.nih.gov/31532959/#:~:text=Polypill%20for%20Cardiovascular%20Disease%20Prevention%20in%20an%20Underserved,usual%20care%20in%20a%20socioeconomically%20vulnerable%20minority%20population.
Multiple Clinical Studies of fixed combination CVD ‘Poly-Pill’ in use in UK, EU, India, showedUp to 50% reduction of secondary heart attacks, strokes owing mostly to better adherence*
* “A Strategy to Reduce Cardiovascular Disease by More Than 80%,”(N. J. Wald and M. R. Law, British Medical Journal)
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International Clinical Data is the Foundation for a Personalized Poly-Therapy
ADOPTION PLAN IS BUILT ON IDENTIFIED PHYSICIAN INFLUENCERS AND HOSPITAL SYSTEMS SEEKING TO REDUCE COSTS ASSOCIATED WITH EMERGENCY ROOM VISITS AND READMITTANCE
Broad Nationwide ImplementationExpansion into Other Combinations outside CVD
Multiple CVD Polypill combinations (1000s/month)
Automation Added
Initial Polypill OfferingSemi automatic
Fulfillment100s/month
Individual Doctors
• Physicians• Large Practices• Hospital Systems
Dr. Anthony Viera, ChairDepartment of Community and Family MedicineProfessor Duke School of Medicine
“Whatever happened to the polypill?”1
BMJ. Mar 27 2017
“Polypill is not just for cardiovascular disease”
Anthony J. Viera, M.D., MPH, would lead the roll out of the fixed dosage polypill made by Panaceutics
“Our desire in partnering with Panaceutics is to diminish costs and boost adherence rates, while offering a more personalized product for patients”
Duane Davis, MD, Chief Medical Officer
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https://youtu.be/kRKsnA4T9RgClick Image to see Florida Hospital’s Video
LARGE IDENTIFIED, ADDRESSABLE MARKET FOR CVD POLY-THERAPIES
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DRIVERS: MANY CONDITIONS SOLVED BY COMBINATIONS
Known Applications:
Cardiovascular
Diabetes
Urology
OBGYN – pre-term birth
Long-haul COVID-19 therapy
Clinical Decision Aid for Cardiologists to rapidly personalize combination therapies
Individual Pharmacogenomics based on published PGx data
Integration of 3rd Party pharmacogenomic formulation toolscorrelating to each patient based on g
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Clinical Decision Support Cloud Tool for Cardiologists Developed by Panaceutics with UNC Eshelman Pharmaceutical Researcher
PolyPill Products can support genetically driven prescribing – to reduce adverse side patient side effects and potential return to care costs
Our R&D Plan continues development of patented variablydosed combination suspension forms and IP with potential for FDA registration• Improving stabilizes of drug intermediates in storage,• Minimized Drug-Drug Interactions and • Improves Bio-availability
Microcapsules average diameter is 350 microns, 30-40% drug loading
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0 0.5 1 1.5 2 2.5 3 3.5 4
Frac
tione
d A
PI R
elea
sed
Hours
Dissolution of Sample 19USP 724 Apparatus II
pH 2 pH 6
Encapsulated API releases at pH 6
Patent Pending “Suspensions Of Encapsulated Pharmaceuticals And Methods Of Making And Using The Same”, (US Patent Application 62/567,779)
Slide 19
Proof of Concept Developments Completed in 2019
PolyPill RoadMap Provides Early Revenue GrowthWhile Producing Valuable Clinical Data
2017-2019 2020 2021 2022 2023
• Multi-Drug Suspension Process• Process Development with Aspirin
(Anti Platelet, Clopidogrel (Plavix)• Microcapsules made 3rd Party
Patents filed on novel stability IP• Bioequivalence trials designed,
costed at $500k per API
Adherence Studies
Poly-Pill Formulation Prescriptions Filled under 503A LicensesLab
Testing
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Automation
Proof Of ConceptDemonstrations, Testing Capsule based Combinations Scaling
IP Development
Suspension based product testing
MD, IRB Approvals
Enabling the Rapid Growth of Personalization
Poly Therapies
Regulatory Platform
Core Technologies
Clinical Nutrition
Our Mission: To be a leader in scalable Personalized Medicine supporting diversified healthcare strategies
• We will pursue a role as a supplier of personalized therapies to hospitals, clinics, and specialized medical providers
• Use our unique technical advantage and regulatory expertise to provide our healthcare partners with economic individualized therapies for large populations of patients with chronic disease
CONFIDENTIAL PANACEA BIOMATX, INC.
Triangle Compounding•503A Market and Regulatory Path to Personalized Medicine•$6M 2020 Revenue, Positive EBITDA > $400k•cGMP, 503B history and expertise•High quality reputation with multiple long-term customers•Licenses to operate in 9 states•Highly skilled pharmacy staff lead by Danny Barnes, RPH, PharmD
PBI Intellectual Property•5 US granted patents, 2 Pending Patents, 7 international patents•Key hospital and physician relationships•International partner / license draft agreement•Exclusive Marketing rights•Formulation trade secrets
Management Expertise
Assets & Core Competency Inputs to Panaceutics Rx
• Expertise in automation and pharmaceutical formulation
• Track record of implementing scalable automation - nutrition
• FDA level regulatory expertise
• Financial management and funding expertise
= Unique Innovation Strengths
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OUR PLAN SCALES NATIONALLY USING A NETWORK OF OF 503A PHARMACY FACILITIES BUILT BY FRANCHISE OR ACQUISITION
Franchise or acquire 503A Compounding sites in key states
Centralized manufacture of consumables API intermediates
Hub and spoke distribution to optimize shipping costs
Regulatory advantages long term
503A Personalization Centers
Subject to Bulk Drug List or demonstration of Clinical NeedFuture 503B FDA Outsourcing Facility To supply integrated system inhouse facilities
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Operating History and Preliminary Financing Model
• History: $8.9 M Consolidated Revenue (CY 2019),
• $7.0 M Pharmacy Revenue2019, Positive EBITDA (CY 2019, 2020)
• New Marketing Plan for Panaceutics Rx, 2021• Finance Plan:
• Seed Round, Q1 2021 to fund polypill rollout, (less than $1 M needed to get to hospital pilots)
• Series A, Q1 2022 based on key milestones• Series B one revenue at $20 M run rate• Potential JV’s and development partnerships
impact funding needs
Experienced Executive Team
Andy GunnVP Quality - Regulatory
• Regulatory Science and Quality Systems Expert
• Head regulatory affairs at St Jude
• Formerly at FDA, Abbott Diagnostics
Edison Hudson, MBA, MSCTO - Co-Founder• Former Executive
iRobot• Factory automation
expert 20+ patents• Seven startups, four
successful exits• Part of 2 IPO teams• Duke MBA, UNC
Morehead Scholar• Oxford UK, AI
L. Staton Noel III, MSCCSO - Co-Founder • Twenty-year
veteran of Glaxo SmithKline Pharmaceuticals
• Biochemist with Masters in Gerontology, MBA
• UNC Director of Technology Transfer
Mark FriedmanCFO
• 25 yrs financial exec•Biotech, Pharma Financial Strategy
• President RTP Capital, Venture Investors
•Portfolio manager for Launch Place Ventures
• Duke Fuqua MBA
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Danny Barnes, PharmD RPh, CPO• Co-founder
Triangle Compounding Pharmacy
• 20 years in compounding pharmacy
• First registered 503B Outsourcing Facility in NC
PANACEUTICS – RX : A NEW ENTITY CREATED ON A SOLID BASE
Products that can replace 5-6 pills for $1.00 to $1.25 a day with 65% gross margins due the patented automation
Formed on the foundation of a long term successful, profitable Compounding Business, Triangle Compounding Pharmacy
Exclusively licensed patents and IP for efficient manufacture of individually dosed automation serving large patient populations created by Panacea Biomatx Inc
Building on relationships with major hospital groups to begin to implement personalized medicine for their “at risk” populations
Unique combination of management talent covering pharmacy, drug development, FDA level regulatory expertise, and robotic process automation
Capability to build a nationwide business based on personalized combination capsule and liquid formulations made on demand to meet individual needs.
Driving the Delivery of Personalized Health
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