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PERSONALIZED MEDICINE AND DIGITAL HEALTH - AUTOMATED Panaceutics Rx LLC A Panacea BioMatx Inc Subsidiary 6 Davis Drive, Research Triangle Park, NC 27709 Edison Hudson, CEO ehudson@panaceutics.com

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Page 1: PERSONALIZED MEDICINE AND DIGITAL HEALTH - AUTOMATED

PERSONALIZED MEDICINE

AND DIGITAL HEALTH - AUTOMATED

Panaceutics Rx LLCA Panacea BioMatx Inc Subsidiary6 Davis Drive, Research Triangle Park, NC 27709

Edison Hudson, [email protected]

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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

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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

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Meeting Urgent Patient Need with Personalized Therapies

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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

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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

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Hospitals & Integrated Healthcare Systems Have Large Financial Incentives to Address Adherence

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CardioVascular and Metabolic Disease Applications of Panaceutics Rx

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https://www.nytimes.com/2019/08/22/health/heart-disease-iran-study.html

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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.

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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

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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

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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

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“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

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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

Page 17: PERSONALIZED MEDICINE AND DIGITAL HEALTH - AUTOMATED

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

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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

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2

3

4

5

6

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8

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0 0.5 1 1.5 2 2.5 3 3.5 4

Frac

tione

d A

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elea

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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

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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

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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

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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

22 1

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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

Page 25: PERSONALIZED MEDICINE AND DIGITAL HEALTH - AUTOMATED

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

Page 26: PERSONALIZED MEDICINE AND DIGITAL HEALTH - AUTOMATED

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.

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Driving the Delivery of Personalized Health