BioSciences, Inc. (OTCQB: PBIO) Discovery Starts with Sample - - PowerPoint PPT Presentation

Pressure BioSciences, Inc.

(OTCQB: PBIO) Discovery Starts with Sample Preparation™ Investor Presentation November 2019

Richard T. Schumacher President, CEO, and Founder

This presentation may contain forward looking statements that reflect management’s current views and opinions as to the status of the Company’s products, technology and other future events and operations. These statements are neither a promise nor guarantee, but involve risks and uncertainties that could cause actual results to differ materially from those anticipated or indicated. Investors are cautioned that any forward looking statements should be considered in light of such risks and uncertainties including, without limitation, those detailed in the Company’s filings with the Securities and Exchange Commission.

FORWARD LOOKING STATEMENTS

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COMPANY OVERVIEW (OTCQB: PBIO) Three Business Segments - Three Unique Technology Platforms

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➢ Research Products and Services (PCT Platform)

• PCT: Pressure Cycling Technology (alternating cycles of high/low pressure to control biomolecules)
• Focus: to streamline and improve the characterization and quality control of protein therapeutics for the

Biopharma market. Also offers an effective means of rapid, consistent, and reliable sample preparation for biomarker and target discovery and clinical diagnostics and research laboratories.

• 15 Patents, 325 PCT Systems installed, 200+ customers, 120+ publications, FY2018 revenue ($2.4M)

➢ Biopharma Contract Services (BaroFold Platform)

• BaroFold: Pressure Enabled Disaggregation and Controlled Refolding of Proteins
• Focus: to improve the quality of protein therapeutics, accelerate therapeutic protein development, and

manufacture follow-on biologics by employing high pressure for disaggregation & controlled refolding of recombinant proteins into their native structures for desired drug activity.

• 8 Patents, Dec 2017 BaroFold Inc. Acquisition, Commercial Launch of BCS Business on Jan 7, 2019

➢ Nanoemulsion Manufacturing Services (UST Platform)

• UST: Ultra Shear Technology (uniquely combines high hydrostatic pressure & intense shear forces)
• Focus: to produce higher quality, more stable nanoemulsions with improved absorption, higher

bioavailability, and lower surfactant levels: results in better quality food, pharmaceuticals, nutraceuticals, cosmetics, and cannabis oil extracts (water soluble CBD) compared to standard emulsions

• 2 Patents, Commercial Launch of BaroShear K45 in July 2019

• Mr. Richard T. Schumacher, President & CEO

Boston Biomedica (CEO, Founder); Panacos Pharma (President, Co-founder); Trinity Biotech (Founding Group); CBR Labs (Gen’l Mgr) - Harvard Medical School

• Dr. Edmund Y. Ting, Senior VP of Engineering

Avure Technologies (CTO); Flow Int’l (VP R&D); Grumman Aerospace; Pioneer in High Pressure Processing for “Clean Label”, Safe Food; MIT (Ph.D.)

• Dr. Alexander V. Lazarev, Senior VP and CSO

Proteome Systems; Genomic Solutions; ESA; University of Kazan (Ph.D.)

• Dr. Alexander V. Lazarev, Senior VP and CSO

Proteome Systems; Genomic Solutions; ESA; University of Kazan (Ph.D.)

• Dr. Nathan Lawrence, Senior Advisor (recently retired VP of S&M at PBI)

Becton Dickinson, Boston Biomedica, 454 Life Sciences, Pressure BioSciences, Inc.

Board

• Jeffrey Peterson, MS

Board Chairman

• Kevin Pollack, Esq., MBA

Chairman: Audit Committee

• Vito Mangiardi, MBA

Chairman: Compensation Committee

• Mickey Urdea, Ph.D.

Chairman: SAB

• Richard T. Schumacher

CEO, Treasurer, Clerk

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COMPANY MANAGEMENT (OTCQB: PBIO)

PCT Platform

RESEARCH PRODUCTS & SERVICES

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QUALITY OF ANALYSES IN RESEARCH STUDIES (DISCOVERY TO CLINIC) DEPENDS SIGNIFICANTLY ON THE QUALITY OF SAMPLE PREPARATION

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Sample Input Quality = Sample Result Quality

THREE CRITICAL FUNCTIONS IN SCIENTIFIC RESEARCH STUDIES

✓Quality of Analytical Equipment & Data Reduction has Increased Over Recent Years ✓Quality of Methods for Sample Preparation have not Increased Proportionally (weak link) ✓Quality of Results is Significantly Affected by the Quality of the Sample Preparation ✓Scientific Discoveries Start with Sample Preparation

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Sample Preparation Analysis Data Reduction & Interpretation

VALUE PROPOSITION: RESEARCH & BIOPHARMA INDUSTRY

• Analysis of Proteins, Lipids, DNA, RNA, and Small Molecules (“biomolecules”)

from Biological Samples is the Backbone of the Research & Biopharma Industry (Discovery to Clinic)

• Quality of Results Depends Significantly on Quality of Sample Preparation
• Current Sample Preparation Methods are Highly Inadequate: Bottleneck
• PCT: Proven Sample Prep Platform with ~ 300 PCT Systems Installed in about 200

Different Sites Worldwide

• 120+ Publications Highlight the Advantages of the PCT Platform in Research,

Biopharma Sample Preparation (from Discovery to Characterization to QC to Clinic), Protein Therapeutics Characterization and QC

• Biological Sample Preparation (Proteomics, Genomics, Lipidomics,

Metabolomics) is a Multi-Billion Dollar Market Comprised of an Estimated 500,000 Scientists in 80,000 Research Labs Worldwide

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GENOMICS (DNA/RNA)

$27.6B by 2025b

NEXT GEN SEQUENCING (DNA)

$16.35B by 2024c

MASS SPECTROMETRY (PROTEINS)

$5.27B by 2022d

SAMPLE PREP FOR ALL OMICS

$9.3B by 2025e

ALL PROTEOMICS

$72.44B by 2021f

ALL BIOPHARMA

$526B by 2025g

500,000 SCIENTISTS IN 80,000 BIOLOGICAL RESEARCH LABS WORLDWIDE a MARKET OPPORTUNITIES: PCT PLATFORM

a EMMES Group |b Research and Markets (August 2018) |c Markets and Markets (Aug 2018) |d Markets and Markets (Nov 2017)

|e Coherent Market Insights (Jan 2019) |f Allied Market Research (March 2019) |g Allied Market Research (July 2018) 9

SPECIFICATIONS

cGxP-compliant Data Logging and Audit Trails

• 16 samples per batch
• Full support for MicroPestle platform
• Pressure: up to 45,000 psi (3.1 kilobar)
• Temperature: 4°C to 95°C (external chiller)
• r Ambient to 95°C (built-in electrical heater)
• Unlimited pressure programming
• Real-time graphs of pressure and temperature
• Enhanced security and user management
• Safe low voltage (24V DC) operation

BAROCYCLER 2320EXTREME FOR BIOLOGICAL SAMPLE PREPARATION & QC (DISCOVERY TO CLINIC)

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PBI INSTRUMENT PORTFOLIO

11 Up to 45,000 psi. Award- winning, next-generation, multi-functional sample preparation instrument

BAROCYCLER™ 2320EXT

Up to 58,000 & 100,000 psi. All-purpose pressure generators

HUB440 - HUB880

Up to 20,000 psi. High throughput analyses

BAROZYME HT48

Up to 58,000

• psi. On-line

sample processors

XSTREAMPCT™

Up to 25,000 psi. Novel Pressure Pump

RF 1700 EXPLORER DISCOVERY PLATFORM

Lab-Scale UST Homogenizers

ULTRA-SHEAR TECHNOLOGY (UST)

1 5 4 3 2 6 7

DISCOVERY CLINIC DEVELOPMENT

APPLICATIONS OF PBI PRODUCTS & SERVICES SPAN ACROSS ALL BIOPHARMA MARKET SEGMENTS FROM DISCOVERY TO CLINIC

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Ced edars Sinai Biomarker Discovery Heart Disease Professor J. Van Eyk

• Prof. Patricia Okubara

Professor Cathy Royer Professor Wayne Hubbell USD SDA – WSU SU Biomarker Discovery Microbe Diversity in Soil Re Renssel elaer Po Poly.

• y. Inst.

Protein Folding Kinetics Rational Drug Design UCLA Protein Structure Drug Discovery & Design Ha Harv rvard Me Medical School Metabolomics/Lipidomics Fecal Lipidomic Profiling Professor Bruce Kristal Professor Bruce McCord

• Prof. Ruedi Aebersold
• Prof. Phil Robinson

Florida Int’l Univ. Forensics – DNA Testing Improved Rape Kit Testing ET ETH, Zuri rich, Swi Switzer erland WW Proteomic Leader Tissue Biopsy Analysis by PCT-SWATH Pr ProCan (CMRI), Syd ydney, y, AU AU Proteomic Mass Spec for Precision Medicine & Therapy

PCT PLATFORM IN THE LABS OF KOLS WORLDWIDE

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BAROFOLD PLATFORM

BIOPHARMA CONTRACT SERVICES & Licensing

Patented Process for Disaggregation and Controlled Refolding of Proteins

• Most New Drugs are Biological not Chemical
• Over 200 Protein Drugs on Market – Many Additional Protein Drugs in Development
• Proteins Can Aggregate and Misfold in Manufacturing: Critical Issue
• Pressure (BaroFold Platform) Can Disaggregate and Refold Proteins: Addresses Critical Issue
• Improves Quality of Protein Drugs and Reduces Cost of Manufacturing
• Potential for Millions of Dollars in Annual Revenue from Biotherapeutic Company Licenses
• BaroFold Technology Works Well on PBI Instruments (R&D)
• Expect Increase in PBI Instrument Sales from Companies Developing Protein-based Drugs

VALUE PROPOSITION: BAROFOLD PLATFORM

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MARKET OPPORTUNITIES: GLOBAL BIOPROCESSING OF PROTEIN-BASED DRUGS

• Monoclonal Antibodies
• Interleukins
• Vaccines
• Growth Factors

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The BaroFold Platform helps companies create novel protein therapeutics, accelerate therapeutic protein development, manufacture follow-on biologics, and enable life-cycle management of protein therapeutics. The BaroFold Platform is scalable and practical for standard manufacturing processes. According to a Report from Transparency Market Research (July 2018), the Global Bioprocess Technology Market will reach an estimated $44B by 2026. ___________________

Disease Indications – Rheumatoid Arthritis – Psoriasis/Psoriatic Arthritis – Cancer – Diabetes

We offer this valuable technology platform through Contract Services, Novel Research-Scale Instrumentation, and Licensing

• Commercial Launch Announced in January 2019
• Contracts Signed (2019) with 2 Multi-Billion Dollar International Companies
• Expect Revenue Increase of $500,000 in BCS (FY2019 vs. FY2018)
• In Discussions with Additional Major Biopharma Companies
• Construction of GMP-Compliant Manufacturing Laboratory On-Going
• Contract Services Team Doubled in Size in 2019
• Additional Specialized BCS Equipment Purchased in 2019
• New and Advanced High-Pressure Protocols Developed in 2019

BIOPHARMACEUTICAL CONTRACT SERVICES (BCS) - BAROFOLD

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DISCOVERY CLINIC DEVELOPMENT

BAROFOLD PATENTS FOR PROTEIN DISAGGREGATION AND CONTROLLED REFOLDING APPLICABLE TO SAME BIOPHARMA COMPANIES AS PBIO’S CORE PCT PLATFORM BUSINESS

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UST PLATFORM

NANOEMULSION PROCESSING EQUIPMENT, LICENSING & SERVICES

VALUE PROPOSITION: ULTRA SHEAR TECHNOLOGY (UST)

The UST platform utilizes ultra-high pressure to create intense, instantaneous liquid shear under controlled conditions to generate ultrafine dispersions of nanoemulsified oil (nanoemulsions) for beverages, cosmetics, nutraceuticals, pharmaceuticals, biotechnology and other product applications.

• Market Opportunity: Nanotechnology holds great promise for enhanced drug delivery as

nanoemulsions are more bioavailable, faster acting, and can be formulated into numerous products including capsules, injectables, sprays and creams

• Problem: “Oil and water” do not mix, and microemulsion mixtures can require large of

amounts of chemical modifiers (e.g. emulsifiers and surfactants) to achieve stability

• Solution: Nanoemulsions that are physics-based (processed with high pressure and

intense shearing forces) require much lower levels of emulsifiers and offer greater product formulation possibilities

• Our Platform: At up to 45K psi, UST is the highest shear stress platform available and

generates high quality, kinetically stable, “oil and water” nanoemulsion formulations using pharmaceutical processes for a very cost-effective way to make CBD Oil water-soluble

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Key Achievements To Date: 2017

EMULSIONS

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• Emulsion: Mixture of Two or More Liquids that do not Usually Mix

Homogenized Milk, Mayonnaise, Vinaigrettes, Vaccines

• Emulsifiers: Required for Solubilizing & Stabilizing Emulsions (Surfactants/Detergents)
• Emulsion Applications: Food, Pharmaceuticals, Nutraceuticals, Cosmetics,

Hairstyling, Cannabis Oil Extracts (CBD, etc.)

• Emulsion Types: Macroemulsions, Microemulsions, Nanoemulsions

Challenge: Increase/Improve the Utilization, Stability, Bioavailability, Absorption, Appearance AND Decrease/Eliminate Need for Chemical Additives (e.g., Surfactants)…Clean Label Science Points to Higher Bioavailability, Improved Absorption, Greater Stability, Reduced Need for Surfactants (10% of Macro/Micro), More Rapid Uptake, Reduction In Food-Borne Pathogens (greater safety), Better Preservation of Flavor/Texture/Color, and More

with Nanoemulsions

MARKET OPPORTUNITIES: UST PLATFORM

• Cannabidiol (CBD):

$89 Billion by 2024

• Nutraceuticals:

$578 Billion by 2025

• Cosmetics:

$805 Billion by 2023

• Inks/Paints/Indust. Fluids:

$25 Billion by 2025

• Biopharma Drug Delivery:

$900 Billion by 2025

• Food & Beverage:

$5.65 Trillion in 2017

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SELECTED CBD MARKET OPPORTUNITIES

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CBD Infused Beverages: $1.4 Billion by 2024

Cannabis-Infused and CBD Beverage Market to Reach $1.4 Billion ACCESSWIRE March 13, 2019

Nutraceuticals: $664 Million by 2022

Top 5 Nutraceutical Trends in 2019 - Cannabis Is In Master Control April 18, 2019

Cosmetics: $645 Million in 2019. CAGR >33%

The Major Factors Expected to Catapult CBD Skin Care Growth Through 2027 Global Cosmetics Industry April 11, 2019

Biopharma: $50 Billion by 2029 Projected cannabinoid-based pharmaceuticals market size in the U.S. from 2020 to 2029 (in billion U.S. dollars) Statista 2019

Walgreens Walgreens to sell hemp-derived CBD products, joins growing list of mainstream retailers The Walgreens pharmacy chain will sell CBD-infused creams, sprays and transdermal patches in 1,500 stores across nine states Hemp Industry Daily March 28, 2019 CVS NutraLife Biosciences Encouraged By CVS Health Corporation's Decision to Distribute CBD at 800 Stores in the U.S. March 22, 2019 (Globe Newswire)

BAROSHEAR K45: FIRST GENERATION UST-BASED NANOEMULSION PROCESSING SYSTEM

Custom Designed Key Components UHP Generator Subsystem. Ideal for small volume processing.

• BaroIsolator. Keeps product from entering

pump, simplifies flow path, eliminates processing loss, and improves cleanliness. NanoGap Valve. Improves process uniformity and scalability by active flow throttling and integrated temperature control. Temperature Control. Built in control before, during, and after shear disruption for maximum product quality and effectiveness. Full Data Acquisition. Easy to use touch screen control and GMP-ready record keeping system.

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UST: PROPRIETARY NANOGAP VALVE™

Ultra-High Pressure Dynamically-controlled value with nanometer-size orifice: creates nanoemulsions

Ultra Shear Technology (UST) nanoemulsions are (i) translucent because the droplets in the dispersion are smaller than the wavelength of light and (ii) stable because these droplets behave like individual molecules in a true solution using Brownian motion to keep them from re-agglomeration

Macro- Emulsion Nano- Emulsion “+” UST CBD Oil & Water Dynamic Control “-” UST

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HIGH POWER UHP PUMP PBI PATENTED SHEAR VALVE TEMPERATURE CONTROL ZONES FILLER INCOMING PRODUCT LOADING PUMP PBI PATENTED ISOLATORS BACK PRESSURE VALVE

UST PROCESS SCHEMATIC

UST combines the effects of ultra high pressure and intense shear in a single process

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The So-called “Water Soluble” CBD Oils We Have Tested to Date:

• Contain CBD that has been chemically modified, or
• Contain substantial amounts of emulsifiers and surfactants, or
• Do not list all the ingredients, and
• None of them dissolve or form clear solutions in water!

Chemical modifications (CBD + cyclodextrin, esterification) Ultrasound: long process CBD + 20 min. blending CBD + glycerol (density modifier) + emulsifiers 27

UST APPLICATION: OIL & WATER NANOEMULSIONS FOR CBD DELIVERY How “Water Soluble” is the CBD Oil on the Market Today?!?

“TRUE” NANOEMULSIONS ARE INVISIBLE UNDER A MICROSCOPE

Conventional Macroemulsion UST Nanoemulsion (droplets below 120 nm)

10 micron 10 micron

“+” UST

Hemp Seed Oil Was Used as the Model System

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DYNAMIC LIGHT SCATTERING SIZING OF UST NANOEMULSIONS

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Z Ave. Dia (nm) PdI SD Dia (nm) Diffusion coefficient (um^2/s)

Peak 1: Mean Diameter Size

(nm)

Peak 1 Mode Dia (nm) Peak 1 Est. MW (kDa) Peak 1 Intensity (%) Peak 1 Mass (%) Peak 1 Diffusion coefficient (um^2/s) 64.78 0.15 24.9 6.616

67.07

67.35 12700 100 100 6.39 66.18 0.13 24.08 6.476

66.82

66.65 12000 100 100 6.414 63.02 0.16 25.32 6.801

68.42

60.96 9390 100 100 6.264

Showing a Homogenous Solution of Nanometer Sized CBD-oil Droplets in Water

OIL & WATER DO MIX – WITH UST PROCESSING!

“Water Soluble?!?” CBD* Formula Commercially Obtained UST- Processed CBD* Formula: PBI

“+” UST “-” UST

*same amount of CBD 30

UST Summary: Advantages of Nanoemulsion Platform

Others Claim to Make Water-soluble CBD, but There Are a Variety of Issues:

▪ High levels of emulsifiers or surfactants and predominantly macroemulsions ▪ Chemical modification or chelator agents are being used ▪ High process temperatures that can cause degradation ▪ Low throughput and inadequate mixing with potential of metal erosion (e.g. ultrasonic methods) ▪ Larger oil drop sizes with poor shelf-stability, poor absorption, and poor bioavailability ▪ Lack of stability in aqueous formulations indicated by milky and cloudy appearance

Our Proprietary Ultra-High Pressure UST Platform Provides:

▪ True nanoemulsions relying on Physics (high pressure) rather than Chemistry (lots of emulsifiers) ▪ Faster, more reliable and easily scalable process ▪ BaroIsolators™ for a cleaner, enclosed system that separates product from pumps / hardware ▪ NanoGap™ Valve for intense shearing and inactivation of pathogens ▪ Exquisite temperature control to maintain product integrity and quality ▪ Clear, translucent appearance and a stable nanoemulsion solution

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USDA Project Goal

As announced on Tuesday, July 10, 2018 USDA funded project ($891K) with Ohio State Univ. and Pressure BioSciences ($318K) Validate and demonstrate commercial (pilot) scale production of high value, high quality dairy products using PBI’s patented Ultra Shear Technology (UST)

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CHEMICAL, THERMAL, & NON-THERMAL PROCESSING FOR FOOD SAFETY

• Chemical. Unpopular. Many consumers now demanding “Clean Label” food products.
• Thermal (heat-based). Variations on time & temperature. Includes Pasteurization to

UHT to HTST to Retort Sterilization. Effective for spoilage/pathogen control but poor

• n quality (nutrition, taste, consumer perception).
• “Non-thermal”. (Processes where heat is not the primary processing factor)

– High Pressure Processing (“HPP”). Food sealed and subjected to uniform high hydrostatic pressure (100-600 MPa) exposure for a set period of time. Ensures microbial safety without addition of chemicals while maintaining flavors and nutritional value. Requires refrigeration post-processing. FDA accepted. – UV, Ozone, PEF. Issues, including consumer perception. Limited FDA acceptance. – Ultra Shear Technology (“UST”). Combines HPP with high shear and hydrodynamic heating (flash of high temperature). Ensures microbial quality (pathogen, spore and spoilage organism inactivation) without addition of chemicals while achieving high sensory and nutritional value. No refrigeration required post-processing (depends on degree of UST).

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Other Markets: High Pressure Instruments and Consumables

HIGH PRESSURE PROCESSING: ACHIEVING HIGH QUALITY, PATHOGEN SAFETY, AND “CLEAN LABEL” IN CERTAIN FOOD PRODUCTS

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Certain foods are currently subjected to non-thermal, High Pressure Processing (HPP) to eliminate the need for chemical additives and quality degrading harsh treatment. HPP is an FDA/USDA accepted non-thermal method to make food safer, last longer, and retain flavor better while keeping a “Clean Label”. It is a recent technology that has experienced rapid growth. The HPP market has been estimated to reach $27.4 billion in 2023 and $51.1 billion by 2027 (FoodSafetyTech 2018).

While HPP can inactivate vegetative forms of pathogens and spoilage organisms in high acid foods, it does not inactivate bacterial spores, has variable effect on enzymes, and does not work well with emulsions/viscous materials. The combination of ultra-high pressure and intense shear forces are required for the effective control - at room temperature - of enzymes and spores… (Ultra Shear Technology, or UST)

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Other Markets: High Pressure Instruments and Consumables

UST PROCESSING OF FOOD & BEVERAGES

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• USDA Goal is for the commercial production of shelf stable, higher quality, low acid foods

such as dairy beverages, nutritional drinks, liquid cheese, and other liquid products.

• UST is expected to achieve product stability with less quality damage than current methods.
• UST is expected to reduce or eliminate the need for stabilizers and other chemical additives

resulting in consumer demanded “Clean Label” food and beverage products.

• UST can also be applied to many non-food applications where small particles, or emulsions

are beneficial such as pharmaceuticals, nutraceuticals, biotechnology, cosmetics and industrial products. UST can inactivate (kill) pathogens, spoilage organisms, and bacterial spores in low acid foods, and thus produce long lived products that do not require refrigeration, while still maintaining higher quality of stability, color, taste and nutrition than retorted products.

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2019 UP-LIST GOAL & SHORT-TERM REVENUE DRIVERS

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Key Achievements To Date: 2017

SHORT-TERM GROWTH DRIVERS

• Research Products & Services (PCT Platform):

Consistent Revenue Stream from Sales of Instruments (Barocycler 2320EXT, Barozyme, HUB) and Consumables to Academic, Government, Biopharma, and Biotechnology Companies

• Worldwide. New Focus (2019) on Improved Characterization and Quality Control of Protein

Therapeutics for the Biopharma Market. Continued Focus on High Quality Sample Preparation for Biomarker and Target Discovery, Pathology, and Movement Down the Path to Clinical Diagnostics.

• Biopharma Contract Services (BaroFold Platform):

Consistent Revenue Stream from Offering Disaggregation and Controlled Refolding Services to Protein Therapeutic Companies, plus the Potential for Millions of $$ from Royalties through Manufacturing Scale Licenses.

• Nanoemulsion Manufacturing Services (UST Platform):

Consistent Revenue Stream from Sales of UST-Based, Proprietary Instrumentation and Consumables for Processing Oil-based Solutions into Stable, Water-Soluble Nanoemulsions. Initial Focus (2019/2020) on Cannabis (CBD) Companies. Beginning in 2021, Focus will Expand to Include the non-Cannabis Nutraceuticals Industry, as well as the Cosmetics and Food & Beverage Industries.

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