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

Pressure BioSciences, Inc.

(OTCQB: PBIO) Discovery Starts with Sample Preparation™ Investor Presentation March 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, 2017 revenue ($2.24M)
• Biopharma Contract Services (Barofold Platform)
• Barofold: Pressure Enabled Disaggregation and Controlled Re-folding 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 Acquisition, Commercial Launch of BCS Business on Jan 7, 2019
• Nanoemulsion Manufacturing Services (UST Platform)
• UST: Ultra Shear Technology (combines high hydrostatic pressure & intense shear forces)
• Focus: to produce higher quality, more stable nanoemulsions with improved absorption, higher

bioavailability, and lower surfactant levels: food, pharmaceuticals, nutraceuticals, cosmetics, lubricants, paint, and cannabis oil extracts (water soluble CBD) compared to standard emulsions

• 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. Bradford A. Young, Senior VP and CCO

AddisonField Corp; Nodality; Quest Diagnostics; Celera; Un. Of MD (Ph.D.), UC Berkeley (MBA)

• Mr. Richard Thomley, Financial Advisor (former PBI CFO, now retired)

Board

• Jeffrey Peterson, MS

Board Chairman Serial Entrepreneur; Abbott, GE; BSChE/MSCE – MIT

• 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 4

COMPANY MANAGEMENT (OTCQB: PBIO)

RESEARCH PRODUCTS & SERVICES

PCT Platform

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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 Sample Preparation Analysis Analysis Data Reduction & Interpretation 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)

$7.1B in 2015b

NEXT GEN SEQUENCING (DNA)

$2.7B in 2017c

MASS SPECTROMETRY (PROTEINS)

$2.7B in 2011a,d

SAMPLE PREP FOR ALL OMICS

$8.4B in 2016e

ALL PROTEOMICS

$21.87B in 2021f

ALL BIOPHARMA

$160.44B in 2014f

500,000 SCIENTISTS IN 80,000 BIOLOGICAL RESEARCH LABS WORLDWIDE a

VALUE PROPOSITION: BIOPHARMA INDUSTRY

a EMMES Group | b Decisive Bio-Insights |c Markets & Markets |d TechNavio |e bcc Research | f Research and Markets

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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 2320EXT: EXTREME INSTRUMENT 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)

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

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Cedars Sinai Biomarker Discovery Heart Disease Professor J. Van Eyk

• Prof. Patricia Okubara

Professor Cathy Royer Professor Wayne Hubbell USDA – WSU Biomarker Discovery Microbe Diversity in Soil Rensselaer Poly. Inst. Protein Folding Kinetics Rational Drug Design UCLA Protein Structure Drug Discovery & Design Harvard 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 ETH, Zurich, Switzerland WW Proteomic Leader Tissue Biopsy Analysis by PCT-SWATH ProCan (CMRI), Sydney, AU Proteomic Mass Spec for Precision Medicine & Therapy

PCT PLATFORM IN THE LABS OF KOLS WORLDWIDE

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BIOPHARMA CONTRACT SERVICES

BAROFOLD Platform

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BAROFOLD Technology Platform Patented Process for Disaggregation and Controlled Refolding of Proteins

8 Issued Patents: Extends Some Current Coverage & Adds New Coverage

• Almost All New Drugs are Biological not Chemical
• Over 200 Protein Drugs on Market – Many Additional Protein Drugs in Development
• Proteins - as Large Protein Molecules - Can Aggregate and Misfold in Manufacturing
• Pressure (Barofold Platform) Can Disaggregate and Refold Proteins
• Improves Quality of Protein Drugs and Reduces Cost of Manufacturing
• Barofold Technology Platform Works Well on PBI Instruments (R&D)
• BaroFold Investors Requested Majority of Purchase Price in PBIO Stock
• Potential to Generate Millions of Dollars in Annual Royalty Revenue from

Biopharmaceutical Company Licenses

BaroFold Asset Acquisition: 12/13/17

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DISCOVERY CLINIC DEVELOPMENT BAROFOLD PATENTS FOR PROTEIN DISAGGREGATION AND CONTROLLED REFOLDING (Pre-EMT) SPAN ACROSS SAME BIOPHARMA COMPANIES AS PBIO’S CORE PCT BUSINESS

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NANOEMULSION MANUFACTURING

EQUIPMENT, LICENSING & SERVICES UST PLATFORM

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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. In 2015, the HPP market was estimated at approximately $10B (Toops, 2016).

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 heat is required for the effective control - at room temperature -

• f 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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Key Achievements To Date: 2017

NANOEMULSIONS: (ULTRA SHEAR TECHNOLOGY - UST)

• 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, THC, etc.)

• Emulsion Types: Macroemulsions, Microemulsions, Nanoemulsions
• Challenge: Increase/Improve the Utilization, Stability, Bioavailability, Absorption, Appearance &

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

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PBI’s patented method allows low cost ultra-shear production

UST First Generation Research-Scale System

Patented PBI UST shear valve (under thermal insulation cover) Computer for control and data acquisition PBI pressure generator with patented single isolator

Research system shows great promise for method development

Single-pass homogenizer with highly scalable “Active Nozzle” valve.

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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 Pilot Process in detail

UST combines the effects of HPP and UHT in a single process

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2019 UP-LIST GOAL & SHORT-TERM REVENUE DRIVERS

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During Q2 2018, 100% of PBI’s Debenture, Promissory Note, & Line-of-Credit Debt Holders (over 40 investors) converted a total of $13.6M of debt into equity, which terminated their lien

• n all assets of PBIO.

This illustration reflects the $13.6M debt to equity conversion for presentation purposes only

Key Achievements To Date: 2017

EFFECT OF $13.6M DEBT TO EQUITY CONVERSION (Q2 2018)

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Loan Debt Before Conversion Loan Debt After Conversion LIABILITIES Revolving note payable 4,000,000

• 0-

Related party debt 42,849

• 0-

Related party, convertible debt 256,161

• 0-

Convertible debt 8,914,450 2,250,826 Other debt 1,448,673 608,673 Accrued interest 2,003,603 175,341 16,665,736 3,034,840

Key Achievements To Date: 2017

SHORT-TERM GROWTH DRIVERS

• Research Products & Services (PCT Platform):
• New Next Generation Barocycler 2320EXTREME
• Field Sales Team Additions (one new sales manager; three more to be added)
• Novel Micro-Pestle Consumable…Potential Use in Pathology, etc.
• 2019 Focus on Biopharma: Characterization and QC of Protein Therapeutics
• PBI Products Fill Existing Needs in $291B (2021 est.) Biopharmaceutical Market
• Biopharma Contract Services (Barofold Platform):

Consistent Revenue Stream from 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 Instruments and Consumables to Food, Cosmetic, and Nutraceutical (CBD, CBG) Companies for Potential Development of Low Cost, Scalable Processing of Liquid Materials into Nanoemulsions

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