This presentation provides an overview of Pressure BioSciences, Inc. Key points include:
- PBI develops instruments and consumables for pressure cycling technology (PCT) sample preparation. PCT uses repeated high-pressure cycles to control molecular interactions.
- PBI's primary market is the biopharma industry, where PCT systems are used from biomarker discovery through validation and quality control. Over 270 PCT systems have been installed.
- A new next-generation PCT instrument, the Barocycler 2320EXTREME, was recently released.
- PBI is also developing ultra-shear technology to produce nanoemulsions for applications in food, pharmaceuticals, and other
2. 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
02
3. 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 Through Q2 2017)
• Q1-Q3 2017: Record Total ($1.7M) & Product ($1.6M) Revenue
• Five 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 Absorption, Rapid Uptake, Better
Bioavailability, Aesthetically Pleasing
• Company Poised for Rapid Growth & to Reach Profitability
4. 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)
5. QUALITY OF ANALYSES IN BIOPHARMA STUDIES (DISCOVERY TO CLINIC)
DEPENDS SIGNIFICANTLY ON THE QUALITY OF SAMPLE PREPARATION
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6. 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 6
7. 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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8. 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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9. PBI INSTRUMENT PORTFOLIO
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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 5432 6 7
10. 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)
or 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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12. 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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13. 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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14. Key Achievements To Date: 2017
SECONDARY MARKET FOCUS: NANOEMULSIONS
• Emulsion: Mixture of Two or More Liquids that are Usually not Mixable/Blendable
(Immiscible)
Homogenized Milk (fat + water + other components), Mayonnaise, Vinaigrettes, Vaccines,
Graphene
• Emulsifiers: Required for Solubilizing & Stabilizing Emulsions
(Surfactants/Detergents/Chemicals)
• Emulsion Applications: Food, Pharmaceuticals, Nutraceuticals, Cosmetics, Hairstyling,
Photography, Industrial Lubricants, Particle Physics, Chemical
Synthesis,
Cannabis Oil Extracts (CBD, THC, etc.)
• Emulsion Types: Macroemulsions, Microemulsions, Nanoemulsions
• Challenge: Increase/Improve the Utilization, Stability, Bioavailability, Adsorption,
Appearance, etc.
Decrease or Eliminate the 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), 2117
15. 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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16. • November 1: PBI Initiates Aggressive Marketing & Sales Strategy Expected to Drive Significant
China Expansion
• October 18: PBI and Phasex Announce Strategic Collaboration Addressing Broad Markets for
Nanoemulsions
• October 10: Expansion of European Biopharma & High Pressure Markets via Multiple Scientific
Presentations
• October 2: PBI issued first two patents in Ultra Shear Technology (“UST”)
• September 18: the Barocycler 2320EXTREME Named a 2017 Finalist in the Prestigious R&D 100
Awards
• August 16: PBI reported record Q2 and YTD total revenue, products/services revenue, and
instrument sales
• June 6: Barocycler 2320EXTREME featured in multiple presentations at the annual ASMS
conference
• 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
• June 2: PBI enacted a 1:30 reverse split as part of the NASDAQ up-list process
• April 17: Joseph L. Damasio, Jr was hired as VP of Finance and CFO
• March 1: Barocycler 2320EXT rec’d the 2017 North American Excellence Award from Corporate
Key Achievements To Date: 2017
KEY ACHIEVEMENTS TO DATE: 2017
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17. 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:
o Additions to Sales & Marketing Team (e.g., from one to five field sales managers in
2017)
o SCIEX Co-Marketing Agreement
o Continued Expansion into Mass Spectrometry Labs Worldwide (est: 16,000)
o New Users & Additional Applications of PCT Platform in Biopharma Market
o Novel Micro-Pestle Consumable
o Recently Released Next Generation Barocycler 2320EXTREME
o Four Additional PCT-based Instruments to be Released over Next 18 Months
o New Ultra-Shear Processing Patent (low cost, scalable production of nanoemulsions)
2121
Hinweis der Redaktion
Undoubtedly, one can obtain an excellent quality data with a top-of-the-line analytical Instrument. However, the data will only be as good as the original sample. The well-known concept of “garbage in - garbage out” applies to any analytical approach, no matter how much we are willing to invest into state-of-the-art instrumentation. Unfortunately, until very recently, the issues of sample preparation have been persistently ignored by the Life Science tools manufacturers.