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

Pressure BioSciences, Inc.

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

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)

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• Develop, Manufacture, & Sell Pressure Cycling Technology (PCT)-Based Instruments & Consumables

Repeated cycles of low to high pressures to control molecular interactions e.g., inactivate enzymes, lyse cells, etc.

• Multiple Potential Markets, e.g., Life Sciences, Food Safety & Science, Material Science, etc.
• Primary Market Focus: Biopharma (PCT Systems for Biomarker Discovery to Validation to QC to Clinic)

~ 270 PCT Systems Installed, 160+ Customers, 100+ Publications…15 Issued Patents

• Exclusive, 2-Year, Worldwide, Co-Marketing Agreement with WW Analytical Instrument Leader SCIEX
• Recently Released, Next-generation, Computer-driven, PCT Instrument (Barocycler 2320EXTREME)
• Revenue: $2.0M in FY16 (One FT Sales Person with Limited Budget Through Q2 2017)
• 1H 2017: Record Total ($1.1M) & Product ($1.0M) Revenue (Led by 16% Increase in Instrument Sales)
• Four Additional Field Sales Managers Hired (vs. One FTE Prior); New Contract with Lead Generator
• CE Marking Achieved on Recently Released Barocycler 2320EXTREME (the “2320EXT”)
• Secondary Market Focus: Nano-emulsions (Made with PBI’s Ultra-Shear Technology, or “UST”)

Two Issued UST Patents (China) for Novel Manufacture of Nano-emulsions…Patent Pending in Rest of the World Potential Applications Include: Food Safety (no preservatives), Cosmetics, Pharmaceuticals, Industrial Lubricants Potential Advantages Include: Improved Adsorption, Rapid Uptake, Better Bioavailability, Aesthetically Pleasing

• Company Poised for Rapid Growth & to Reach Profitability

Management

• 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

• Mr. Joseph L. Damasio, Jr., CPA, VP of Finance and CFO

CP Bourg, IQE KC, Kopin, PBI, KPMG Consulting, PWC; Boston College (MBA, MFS)

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

Avure Technologies (CTO); Flow Int’l (VP R&D); Grumman Aerospace; MIT (Ph.D.)

• Dr. Alexander V. Lazarev, VP of R&D

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

• Dr. Nathan P. Lawrence, VP of Sales & Marketing, Heads of Manufacturing

Boston Biomedica; BD; Gene-Trak Systems; Yale University (Ph.D.)

Board

• Jeffrey Peterson, MS

Board Chairman

• Kevin Pollack, Esq., MBA

Audit Committee Chairman

• Vito Mangiardi, MBA

Compensation Committee Chairman

• Mickey Urdea, Ph.D.

SAB Chairman

• Richard T. Schumacher

CEO, Treasurer, Clerk

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COMPANY OVERVIEW (OTCQB: PBIO)

QUALITY OF ANALYSES IN BIOPHARMA 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: BIOPHARMA INDUSTRY

• Biological Samples are key starting materials of Biomedical Research…these are the

Cells, Tissues, Organs, and Organisms from which are Obtained Novel Biomarkers and other Critical Translational Information

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

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

• Quality of Results Depends Significantly on Quality of Sample Preparation
• Biological Sample Preparation is a Multi-Billion Dollar Market Comprised of an

Estimated 500,000 Scientists in 80,000 Research Labs Worldwide

• Current Sample Preparation Methods are Highly Inadequate: Bottleneck
• PCT is a Proven Sample Prep Platform with ~ 270 PCT Systems Installed (~150 Sites)
• 100+ Publications Highlight the Advantages of the PCT Platform in Biopharma Sample

Preparation (from Discovery to Characterization to QC to - Potentially - the Clinic)

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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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PBI INSTRUMENT PORTFOLIO

9 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

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 (DISCOVERY TO CLINIC)

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PROTEOMICS Genomics, NGS Lipidomics Metabolomics PCT APPLICATIONS IN OMICS SPAN ACROSS ALL BIOPHARMA MARKET SEGMENTS FROM DISCOVERY TO CLINIC

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DEVELOPMENT DISCOVERY CLINIC

DISCOVERY CLINIC DEVELOPMENT APPLICATIONS OF PBI PRODUCTS 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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SCIEX Announces Alliance with CMRI on Feb 3, 2016 CMRI Designated Official Collaborator – US Cancer Moonshot – by VP Joe Biden on July 16, 2016

• CMRI will test 70,000

tumor samples by PCT-SWATH

• CMRI has purchased 4

SCIEX MSs, 3 PBI Barocyclers & PCT Consumables

• First of what could be

many centers WW for “industrialized proteomics”

Dr Dr. Phil Robin inson, Co Co-Head

• f
• f

CMRI, said id: “sample siz ize has has In In th the past lim imited th the use use of

• f mass spec-

based proteomics in in clin inical research but but th the use of

• f PCT will

now allo llow researchers to to analyze tis issue samples as as small as as ones pro provided by by ne needle biopsies”.

• Dr. Phil Robinson

CHILDREN’S MEDICAL RESEARCH INSTITUTE (AUSTRALIA)

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SEARCHING FOR PROTEIN BIOMARKERS FROM TUMOR SAMPLES

ProCan, CMRI, Sydney, AU

Thomas P. Conrads, PhD Associate Director of Scientific Technologies Inova Schar Cancer institute 15

• Dr. Philip Robinson

ProCan (CMRI), Sydney, AU Proteomic Mass Spec for Precision Medicine & Therapy

PCT-assisted digestion for tissue proteomic biomarker discovery

PROGRAM AIMS TO ACCELERATE RESEARCH & SUPPORT OTHER CHANGES THAT WILL IMPROVE THE ABILITY TO PREVENT, DETECT, TREAT, & CURE CANCER

• Announced by President Obama in Jan 2016
• VP Biden Continues to Play Major Role
• Approximately $1 Billion will be used to

Support the Program

• The US National Cancer Institute (“NCI”) will

Coordinate the Effort

• Academia, Industry, Government Laboratories

WW will Collaborate

PBI’s Barocycler 2320EXTREME to Play Important Role in the Cancer Moonshot Initiative

CANCER MOONSHOT INITIATIVE

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Key Achievements To Date: 2017

SECONDARY MARKET FOCUS: NANOEMULSIONS

• Em

Emul ulsion: Mixture of Two or More Liquids that are Usually not Mixable/Blendable (Immiscible)

Homogenized Milk (fat + water + other components), Mayonnaise, Vinaigrettes, Vaccines, Graphene

• Em

Emul ulsifiers: Required for Solubilizing & Stabilizing Emulsions (Surfactants/Detergents/Chemicals)

• Em

Emul ulsion App pplicati tions: Food, Pharmaceuticals, Nutraceuticals, Cosmetics, Hairstyling, Photography, Industrial Lubricants, Particle Physics, Chemical Synthesis, Cannabis Oil Extracts (CBD, THC, etc.)

• Em

Emul ulsion Type ypes: Macroemulsions, Microemulsions, Nanoemulsions

• Ch

Challe llenge: Increase/Improve the Utilization, Stability, Bioavailability, Adsorption, Appearance, etc. Decrease or Eliminate the Need for Chemical Additives (e.g., Surfactants)…Clean Label

Sc Scie ience Poin

• ints to
• Highe

Higher Bi Bioa

• avail

ilabil ilit ity, Imp mproved Ads Adsorptio ion, Gr Greater St Stabilit ility, Reduced Ne Need for

• r Su

Surf rfactants (10 (10% % of

• f Macro/M

/Micro),

• ), Mor
• re Ra

Rapid Uptake; Reduction In n Foo

• od-Bor
• rne Pathog
• gens (gr

greater safety); ); Be Better Preserv rvatio ion of

• f Fl

Flavor

• r/T

/Texture/C /Col

• lor, and

and Mo More

with Nanoemuls lsions

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Other Markets: High Pressure Instruments and Consumables

NANOEMULSIONS (thru Ultra Shear Technology – “UST”)

• Two patents recently issued in China. Patents also filed in US, Canada, Europe, and Asia.
• Positive effects of UST processing are seen in pathogen (spores) inactivation, improved bioavailability,

enzyme inactivation, reduction in stabilizer use, and improved stability

• Nanotechnology applications for food products (stability and safety), as well as for pharmaceuticals

(i.e. drug delivery), cosmetics, industrial lubricants, cannabis oil extracts (CBD)

• Emerging food technology for “clean label products” with extended shelf life, improved quality and

nutrition…clean label food market (lead by High Pressure Processing or HPP) estimated at $62 billion (U.S.) & $165 billion globally (Nunes, 2016)

• Market for the HPP equipment estimated at $ 600M in 2015 (PBI - based on Civil Eats Article)

Nutritional drink Emulsion, nano-emulsion UST: Novel Technique for the Manufacture of Nanoemulsions Using Intense Shear Stresses Generated from Ultra-High Pressure Valve Discharge (greater than 20,000 psi) Current 2320EXT next to UST pilot plant concept

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Other Markets: High Pressure Instruments and Consumables

HIGH PRESSURE PROCESSING (HHP) OF FOOD

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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 food 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.

Th The e com

• mbinati

tion

• n of
• f ultr

tra-high pressure re and heat eat is require red for

• r th

the e eff effecti tive con

• ntro

trol - at t roo

• om tem

emperature re -

• f enzymes and spores… (Ultra-Shear

r Tech echnolog

• gy,

, or

• r UST)

T)

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• Oct

ctober r 2: : PBI issued first two patents in Ultra Shear Technology (“UST”)

• Se

September r 18: : the Barocycler 2320EXTREME Named a 2017 Finalist in the Prestigious R&D 100 Awards

• Aug

ugust t 16: : PBI reported record Q2 and YTD total revenue, products/services revenue, and instrument sales

• Jun

June 6: : the Barocycler 2320EXTREME was featured in multiple presentations at the annual conference

• f the American Society for Mass Spectrometry (ASMS)
• Jun

June 5: : Prof. Ruedi Aebersold, a world renown protein chemist & winner of the prestigious Karger Medal from the Barnett Institute, discussed his laboratory’s use of PBI’s PCT Platform in the two Medal Lectures

• Jun

June 2: PBI did a 1:30 reverse split as part of the NASDAQ up-list process

• Apri

pril 17: : Joseph L. Damasio, Jr was hired as VP of Finance and CFO

• March 23:

: PBI announced the hiring of two full-time field sales managers and the intent to hire up to three more; EKG Associates was hired to generate sales leads

• March 1:

: the Barocycler 2320EXTREME received the 2017 North American Excellence Award from Corporate America News for “Best New Instrument for Sample Preparation”

• Febru

ruary ry 2: : the Barocycler 2320EXTREME met the requirements of CE Marking

Key Achievements To Date: 2017

KEY ACHIEVEMENTS TO DATE: 2017

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Key Achievements To Date: 2017

SHORT-TERM GROWTH DRIVERS

• Exclusive, 2-Year, WW, Co-Marketing Agreement with Global Leader SCIEX
• 2017 M$S Expansion: 5 Additions in U.S. Field Sales Force; Int’l Distributors Added
• Company Focused on Up-list to NASDAQ in 2017
• Next Generation Barocycler 2320EXT Currently Used in Multiple “Cancer Moonshot” Sites
• Company Expects Collaborations with Key Opinion Leaders to Continue…& Grow
• Company’s Products Currently Being Adopted by Multiple Segments of the $160B Biopharma Market
• Company Expects Revenue Growth to be Driven by:
• SCIEX Co-Marketing Agreement
• Continued Expansion into Mass Spectrometry Labs Worldwide (est: 16,000)
• New Users & Additional Applications of PCT Platform in Biopharma Market
• Novel Micro-Pestle Consumable
• Recently Released Next Generation Barocycler 2320EXTREME
• Four Additional PCT-based Instruments to be Released over Next 18 Months
• Additions to Sales & Marketing Team (e.g., from one to five field sales managers in 2017)
• New Ultra-Shear Processing Patent (low cost, scalable production of nanoemulsions)

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Pressure BioSciences, Inc.

(OTCQB: PBIO)