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8-K - CURRENT REPORT - PRESSURE BIOSCIENCES INCpbio_8k.htm
EX-99.2 - PRESS RELESE - PRESSURE BIOSCIENCES INCpbio_ex992.htm
Investor Presentation

Pressure BioSciences, Inc.
(OTCQB: PBIO)

Discovery Starts
with Sample Preparation™


Richard T. Schumacher
President & CEO
rschumacher@pressurebiosciences.com

SeeThruEquity NYC

November 12, 2013

        
  
   

 
 

 
Forward Looking Statements
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.
   
       
 2
 
 

 
 
 
   Pressure Cycling Technology (PCT): Powerful, Enabling, Patented
   Primary Application: Sample Preparation ($ Billion Market Opportunity)
 
   PCT Products Offer Significant Advantages Over Competitive Methods
 
   Proven Technology: ~ 235 Installations in ~150 Marquee Laboratories
   Attractive “Razor/Razorblade” Business Model
 
   On-going Discussions with Large Potential Strategic Partners
   Experienced Management Team and Board of Directors
   Favorable Market Valuation for the Investor
   Active Commercialization of PCT Platform Has Begun
   Two Recent Technical Breakthroughs Reported
   Record Revenue Reported Q3 2013; Strong Guidance for Q4 2013
Key Investment Highlights
3
 
 

 
  Formed Sept 2004 - Sale of Boston Biomedica (BBII)
  Started Operations in 2006
  OTCQB: PBIO
  Ten (10) Full-time Employees
  Strong Management Team and Board of Directors
  Focused on the Development and Commercialization of
 PCT-based Instruments and Consumables for the Preparation
 of Biological Samples for Research Laboratories
  Strong IP - 24 Issued PCT Patents with More Pending
           *
Company Background
 
 

 
 Historical Revenue Data  
  FY 2011    $ 988,000
  FY 2012    $ 1,256,000
  FY 2013 (thru Q3)  $ 1,150,000
 Selected Data: November 11, 2013
  Cash/AR   ~$ 0.28 million
  Inventory   ~$ 0.87 million
  Debt (other than AP)  $ 450K
 Selected Data: September 13, 2013
  Common O/S   11.9 million
  Preferred (common equiv) 8.3 million
  Total CSs and CS Equiv O/S 20.2 million
  Warrants & Options  13.0 million ($0.40 - $3.00)
  Price per Share   $ 0.21
  Market Cap (Com/Pfd)  $ 4.2 million
         
 
 
Financial Data
5
 
 

 
 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
 
  Dr. Edmund Y. Ting, Senior Vice President of Engineering
   Avure Technologies (CSO); Flow Int’l (CSO); Grumman Aerospace; MIT (Ph.D.)
  Dr. Alexander V. Lazarev, Vice President of R&D
   Proteome Systems; Genomic Solutions; ESA; University of Kazan (Ph.D.)
  Dr. Nathan P. Lawrence, Vice President of Marketing
   Boston Biomedica; BD; Gene-Trak Systems; Yale University (Ph.D.)
  Mr. Conrad Mir, Chief Financial Officer
   Genetic Immunity (CEO); Advaxis; Sanford Bernstein; First Liberty; Nomura
 Board
  Jeffrey Peterson, MBA,  Chairman
  Kevin Pollack, Esq., MBA,  Audit Committee Chairman
  Vito Mangiardi, MBA,   Compensation Committee Chairman
  Mickey Urdea, Ph.D.,  SAB Chairman
  Richard T. Schumacher
            *
 
Experienced Senior Management & Board
 
 

 
  Analysis of DNA, RNA, Proteins, & Lipids (“biomolecules”) is
 Crucial to the Development of New Diagnostics & Therapeutics
  Sample Preparation is Required Prior to Virtually All Analyses
  Current Sample Preparation Methods Highly Inadequate: bottleneck
  PCT Offers Clear Advantages Over Current Competitive Products
  Current Target: Life Sciences Research Market - minimal regulatory
  PBI Holds 24 Issued PCT Patents in Multiple Sample Prep Applications
  Early Traction…about 235 PCT Systems installed through Q1 2013
  $6 Billion Market Opportunity for Sample Preparation Products* **
  ~ 500K Scientists in ~ 80K Labs WW require sample preparation
   *Strategic Directions Int’l; **The Emmes Group
          *
 
Value Proposition - Sample Prep Market
 
 

 
Release Important Biomolecules by Cell Lysis
8
 
 

 
Scientific research can be broken down to three key elements:
sample preparation, analysis, & data reduction/interpretation
“Discovery Starts with Sample Preparation”
        
         
Sample Input Quality = Sample Result Quality
9
 
 

 
Competitive Landscape
 Mortar & Pestle
 Dounce homogenizer (glass on glass)
 Potter-Elvenhjem homogenizer (Teflon on glass)
 Enzymatic Digestion
 Polytron shearing homogenizers
 Blenders
 Bead Beating
 Sonication
 Repeated Freeze/Thaw cycles
 French Press (2000 PSI)
Mostly Commodity Products Through Catalogue Sales
10
 
 

 
Barocycler™
NEP2320
PCT Sample Preparation System
11
PULSE Tube
MicroTubes
PCT-dependent Kits
 
 

 
 Next Gen PCT Platform: HUB Family of Barocyclers
  High Pressure Generators
 for Multiple Research & Mfg Applications
 Compact
 Portable
 Versatile
 Computer Controlled
 Labview Software Driven
 Pressures to:
  20 kpsi (HUB160) 2012
  60 kpsi (HUB440) 2012
  100 kpsi (HUB880) Q12014
 
12
…the HUB for every laboratory’s high pressure needs via
 state-of-the-art, application specific modules & software
 
 

 
Product Pipeline (2011 Release)
The Shredder SG3
Low Shear, Mechanical, Homogenization
Device
 Long lasting lithium
  rechargeable batteries
 
 Paddle for convenient
  pressure setting
 
 Pressure force levels:
  15, 30, 45 lbs. Force
 
 Uses PCT PULSE and
  Shredder Tubes
 
 Heavy Duty, Robust Driver
Cole Parmer, a Thermo Fisher Company, and
a Major Worldwide Distributor of Lab
Products, Announced in Oct 2012 that They
will Distribute the Shredder SG3
13
 
 

 
Selected Marquee Customers (40 of 150)
 Amgen
 Biogen
 Lilly
 Novartis
 Monsanto
 BM Squibb
 Merck
 Centocor
 Takeda Pharmaceuticals
 Momenta Pharmaceuticals
 US Army
 FBI
 Food and Drug Administration
 US Department of Agriculture
 National Institutes of Health
 Armed Forces Inst. of Pathology
 Centers for Disease Control
 USAMRIID
 Dana Farber Cancer Center
 Burnham Research Institute
 Thermo Fisher
 Target Discovery
 Battelle Memorial Institute
 Harvard Medical School
 Harvard School of Public Health
 Rockefeller University
 University of New Hampshire
 Barnett Research Inst (NEU)
 UCLA
 UC - San Diego
 UC - Davis
 Lawrence Livermore
 Stanford University
 University of North Texas
 Mississippi State
 Montana State
 Lawrence Berkeley
 University of Kentucky
 Florida Int’l University
 UMASS - Boston
    
     
  
14
 
 

 
 High Level Overview of Current Fields of Use and Applications for PCT:
a Few Select Examples
15
Proteomics (Proteins)
 Biomarker Discovery: Heart Disease and Cancer
 Pressure-Enhanced Enzymology: Trypsin and Deglycosylation
 Enhance/Enable Protein Analysis: Mass Spectrometry, EPR, ESR, and NMR
 Enhance Protein Extraction from FFPE: Diagnostics and Drug Development
 Biopharmaceuticals, Vaccines, and Biosimilars: Discovery, Synthesis and QC
Genomics (DNA, RNA)
 Forensics: Rape Kit Analysis, Bone, and Touch Samples
 Enhance DNA Sequencing: DNA Shearing
 Agriculture: HLB Disease (Greening Disease in Citrus) and Soil Pathogens
 Environmental Biology: Oil Eating Bacteria
 Antibioterror: Rapid Identification and Inactivation
Transcriptomics (RNA): Gene Expression and Drug Discovery
Lipidomics (Fats): Lipid Analysis of fecal material, Metabolomic Diseases, E.g. Diabetes
Mitochondria: Mitochondrial-related Diseases E.g. MDys, Autism,C .Palsy
Food: Pathogen testing, Manufacturing
Herbal Medicine: Discovery, Manufacturing
Chemical: High Pressure Chemical Syntheses and Analysis
Industrial Applications: Automotive, Oil Well Discovery and Recovery
 
 

 
 PCT Focus Area: Biomarker Discovery
Dr. Andreas Huhmer - Thermo Fisher Scientific
  …advantages of speed and quality using PCT in mass spec workflow
Dr. Michael Alterman - Tumor Vaccines and Biotechnology Branch, CBER, FDA
  …improved influenza vaccine quality using PCT in mass spec workflow
Dr. Alexander Ivanov - Harvard School of Public Health
 …improved membrane protein identification using PCT in mass spec workflow
Dr. Bruce McCord, Florida International University
 …improved processing of forensic (rape kit) samples using PCT
 
Dr. Luke Schneider, Target Discovery, Inc.
 improved membrane protein recovery in ovarian cancer studies using PCT in mass spec workflow
Dr. Bruce Budowle, Health Science Center, University of North Texas
  …improved detection of DNA in forensic samples using PCT
      
 
Forensics
Cancer, Heart Disease, Inf. Diseases, Neurological Disorders, Etc.
Dr. Henry C. Lee, the Henry C. Lee Institute of Forensic Science
 evaluation of PCT in the recovery and detection of DNA in difficult forensic samples
Dr. Jeff Mason and Dr. Carol Fowler, Armed Forces Institute of Pathology
 ...improved processing of FFPE (histology) samples using pressure
Dr. Jennifer Van Eyk, Johns Hopkins School of Medicine
 …improved recovery of aorta proteins from FFPE samples using PCT  
16
 
 

 
Professor Wayne Hubbell - UCLA
"Protein flexibility is the new frontier in understanding protein
function and regulation. The study of proteins under pressure
has great ability to reveal salient features of protein flexibility,
and hence provide new insights into protein function and
rational drug design. In my opinion, high pressure will
play a central role in the discovery process that lies ahead in
the exciting field of protein science, and PBI’s PCT Product
Line will make major contributions to this field.”
December, 2012
   
       
 17
Distinguished Professor of
Chemistry & Biochemistry,
and Jules Stein Professor at
UCLA
 
 

 
Dr. Henry C. Lee
“We are excited about this opportunity to collaborate with
Pressure BioSciences to examine the potential applications of
their PCT Platform in improving the collection of forensic
evidence, particularly DNA, in several important areas of
forensics…such collaborations not only provide new, effective
technologies for forensic DNA testing of samples that have
been difficult or unsuitable using today’s standard techniques,
but can also provide new and more effective ways to
reexamine old biological evidence in cold cases.”
   
       
 18
Professor of Forensic Science and
founder of the Forensic Science
Program at the University of New
Haven; founder of the HC Lee
Institute of Forensic Sciences; and
former Commissioner of Public
Safety for the State of Connecticut.

 
 

 
2013 News of Interest
 PBI Reports Record Financial Results (revenue) for Q3 2013

 Guidance Given for Strong Q4 2013 Revenue

 Guidance Given on Two New Instrument Systems (Q1 and Q2 2014)

  PBI Announces Close of $2.0 Million Above-Market Private Placement

 Core Technology Breakthrough Announced

 Novel Method Published for Lipid Analysis in Fecal Material Using PCT

 Further Advances Reported in Improved Rape Kit Testing Method Using PCT

 Dr. Mickey Urdea Joins Board (Feb 2013); Pollack & Mangiardi in July 2012

 Sales Reach Expanded to Approximately 20 Countries Over Past Year

 PBI and Constant Systems Announce Strategic Partnership

 Improvements in DNA Yield from Forensic Samples Reported



 
        
19
 
 

 
2013 Key Product Drivers (High Throughput PCT)

 
Breakthrough in Core PCT Technology Platform - High Throughput
 a) announced on June 4, 2013
 b) will allow PCT sample processing with universal, high throughput multiwell format
 c) will allow PCT Systems to integrate with HT instruments in thousands of labs WW
 d) is expected to significantly accelerate discussions with potential strategic partners
  e) is expected to have significant impact on PBI’s revenue growth, starting Q2 2014


 
Barocycler HUB880 - pressure up to 100,000 psi
 a) first of its kind
 b) will allow scientists to go to 100,000 psi
 c) Q1 2014 release


 
Novel PCT-based Method for Lipid Analysis in Fecal Material
 
a) announced on May 16, 2013
 b) collaboration with Dr. Bruce Kristal and Team at HMS and B/W Hospital, Boston
 c) could provide a reproducible, generally applicable, broad-based, non-invasive
 technique for establishing GI function in patients regardless of age/disease
 d) could significantly impact diagnosis, treatment, cure, and prevention of
 GI diseases/disorders, e.g., colon cancer, inflammatory bowel disease, obesity
 e) could offer new paradigm for nutritional, infectious, & inflammatory status

        
20
 
 

 
2013 Potential Drivers
21
 
 

 
2013 Potential Drivers: High Throughput PCT
         
 
Automated liquid handling helps ensure accuracy and reproducibility,
 eliminates repetitive tasks, and frees personnel for other activities.
22
 
 

 
HT PCT Product Concept
2013 Potential Drivers: High Throughput PCT
23
 
 

 
2013 Potential Drivers: High Throughput PCT
Beta Units Ready for Testing:   February 2014

Beta Site Evaluation Completed:  April 2014

Commercialization:    June 2014

Initial Applications
 rapid protein digestion (multiple labs, worldwide)
 lipid profiling (multiple diseases/disorders of the GI tract)


HTP PCT Platform
 will use new Barocycler HUB or modified instruments
 will use new accessories and modules
 will use new multiwell plate consumables
 will use liquid handling automation, e.g., LEAP Technologies

Strategic Partnerships:  Discussions Have Been
     Accelerated






 
        
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