This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
1. Investor Presentation
Pressure BioSciences, Inc.
(OTCQB: PBIO)
Discovery Starts
with Sample Preparation™
RedChip Global Online Growth Conference
January 25, 2017
Richard T. Schumacher
Founder, President, and CEO
2. 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.
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3. • 9 FT Staff; Near Boston, MA; Publicly Traded (OTCQB: PBIO)
• 15 Patents: Pressure Cycling Technology (“PCT”) Platform
• Develop, Mfg, & Sell PCT-based Instruments & Consumables
• Initial Focus in Sample Preparation for the Research Market
• ~ 275 PCT Systems Installed, 150+ Customers, 100+ Publications
• 30M Common Shares OS (75M CSE Fully Diluted)
• Revenue: FY2014 ($1.3M); FY2015 ($1.7M); Q1-Q3 2016 ($1.56M)
• YTD Accomplishments:
– Q3 2016: Record Product Revenue for Quarter and 9-month Period
– Closed $2M Line-of-Credit and $610K PIPE – both at favorable terms to shareholders – cleaned
up BS (100% VRD Paid-off)
– Next Gen Barocycler 2320EXTREME Released; Multiple Units Sold for Cancer Moonshot Use
– Co-Marketing Agreement with SCIEX (WW analytical technologies leader) – a DHR Company
Company Overview (OTCQB: PBIO)
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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
• Dr. Edmund Y. Ting, Senior VP of Engineering
Avure Technologies (CSO); Flow Int’l (CSO); 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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Experienced Senior Management & Board
6. 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
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n Quality
Sample
Preparation
Quality
Sample
Results
7. • Analysis of DNA, RNA, Proteins, & Lipids (“biomolecules”)
is Crucial to the Discovery of New Biomarkers – Quality of
Results Depends on the Quality of Preparation
• Biological Sample Preparation is a Multi-Billion Market
Comprised of an Estimated 500,000 Scientists in 80,000
Research Labs Worldwide
• Current Sample Preparation Methods are Mostly Mechanical
and are Highly Inadequate: Bottleneck
• Proven Platform: ~ 275 PCT Systems Installed (~150 Sites)
• 100+ Publications Highlight Advantages of PCT Platform Over
Other Methods
Value Proposition: PCT-based Biological Sample Preparation
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8. Estimated Market
• Genomics (DNA/RNA) $7.1B in 2015 b
• Next Gen Sequencing (DNA) $2.7B in 2017c
• Mass Spectrometry (Proteins) $2.7B in 2011a,d
• Forensic Tools and Products (DNA) $17.7B in 2019 e
• Sample Prep for all OMICS: $8.4B in 2016 f
• 500,000 Scientists in 80,000 Biological Research Labs WW a
a
EMMES Group b
Decisive Bio-Insights c
Markets & Markets
d
TechNavio e
Transparency Market Rsh f
bcc Research
Biomarker/Forensics Market: Estimated Size
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11. PCT Platform: Enabling the Enablers
Eight Impact Areas
Where PBI’s Powerful and Enabling
PCT Platform is Currently Being Used…
1. Agriculture/Food Science 2. Environmental Epidemiology
3. Anti-Bioterror 4. Rational Drug Design
5. Biomarker Discovery 6. Fecal Lipidomic Profiling
7. Personalized Medicine 8. Improved Rape Kit Testing
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12. Professor Wayne L. Hubbell
UCLA
• Distinguished Professor of Biochemistry
• Member, National Academy of Sciences
• Fellow, American Academy of Arts and Sciences
Molecular structure of a protein and the conformational changes
that control its function are key to better drug design and development
Conclusion
Response to Pressure May Have Profound Implications in
Future Drug Design & Development
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Rational Drug Design and Development
13. Professor Jennifer Van Eyk
Cedars-Sinai Medical Center
• Professor Of Medicine
• Director, Basic Science Research,
the Barbara Streisand Women’s HC
• Over 1 billion archived formalin-fixed paraffin-embedded (FFPE) samples
• Combination of heat and elevated pressure increased protein yield from
FFPE aorta samples, resulting in significantly more proteins identified
Conclusion
Results suggests that archival and often rare FFPE aortas and other
tissues from patients with clinical histories that often span
decades could potentially be invaluable if made available for PCT-
enhanced
biomarker discovery and quantification
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Biomarker Discovery
14. Non-invasive Fecal Lipidomic Profiling
Professor Bruce Kristal
Harvard Medical School
• Neuroscientist, Brigham and Women's Hospital, Boston
• Associate Professor of Neurosurgery,
• Molecular Biologist, Expert in Metabolomics
• Better analysis of fecal material will facilitate the understanding of gut
(patho)physiology and its role in health and disease and will help
improve care for individual patients, especially infants
• Pressure cycling differentially increased the yield of a number of lipids
Conclusions
Non-invasive fecal lipidomic profiling to define gut function
in health and disease could help physicians assess
intestinal function, determine gut response to nutrition,
and recognize existing inflammation/pathology…
especially valuable in infants and the elderly 14
15. Professor Bruce McCord
Florida Int’l University
• Professor of Analytical/Forensic Chemistry,
• Over 75 peer reviewed papers and 11 book chapters
An estimated 400,000 untested rape kits in the USA
(The Dark Side of Clearing America’s Rape Kit Back-log, Time Magazine 2013)
• Current studies focus on a novel technique to extract biological fluids from
cotton swabs with high recovery using the PCT platform
Conclusion
Short extraction times, high yields, inexpensive reagents
and semi-automated platform make alkaline lysis-based PCT
a promising candidate for extracting DNA from rape kits with the
potential additional benefit of reducing the current backlog 15
Improved Rape Kit Testing
16. Professor Ruedi Aebersold
•Inst of Molec Sys Biology - ETH Zurich
• Professor of Systems Biology
• Scientific Advisory Committee of numerous public and
private research organizations; member of several
editorial boards in proteomics & genomics
Rapid mass spectrometric conversion of tissue biopsy samples
into permanent quantitative digital proteome maps. Nature Medicine March
2015
Conclusion
Authors expect wide applications of PCT-SWATH
in personalized medicine, and believe that PCT-SWATH may
ultimately achieve clinical adoption
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Personalized Medicine: Analysis of Tissue Biopsies
17. Weild & Co. Holdings
CEO, Co-Founder
• Former Vice-Chairman of NASDAQ
• “Father of the JOBS Act” (Forbes Mag)
• Former Head of Global Equity Transactions,
Prudential Securities
• Former President, PrudentialSecurities.com
• Former Head, Capital Markets Group of Grant Thornton LLP
Weild & Co. has been Retained to Consult & Advise
PBI Management & Board of Directors
Mr. David Weild IV
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18. •Q1: Close of Over-Subscribed $5M PIPE at $6.3M
•Q1: 100% (almost $3M) of all Variable Rate Debt Eliminated
•Q1: Co-Marketing Partner Announced (Jan): SCIEX!
• Global leader in life sciences analytical technologies, incl. Mass Spec
• Wholly-owned subsidiary of the Danaher Corporation (NYSE: DHR)
• PBI and SCIEX will Co-Promote PCT-SWATH
•Q2: Next Generation Barocycler 2320EXTREME Released –
Multiple Units in the NCI’s Cancer Moonshot Initiative (CMRI, etc.)
•Q3: Record Products Revenue for Q3 and YTD
•Q4: Close of $2M Line-of-Credit and $610K ($2.5M PIPE)
•Q4: Cancer Moonshot Initiative Signed into Law – PBI Reasserts
Continuing Focus on this Opportunity
Key Achievements: 2016
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19. Children’s Medical Research Institute (Australia)
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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. Phil Robinson, Co-Head of CMRI, said: “sample size has
In the past limited the use of mass spec-based proteomics
in clinical research
but the use of PCT will now allow researchers to analyze
tissue samples as small as ones provided by needle biopsies”.
20. Initial Commercial Application: Mass Spectrometry
(“First Killer App”)
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The Following Information is for Discussion Purposes Only – Not Guidance
Biomarker Discovery (Enhanced Mass Spectrometry Sample Preparation)
We Believe:
• there are approximately 16,000 MS labs worldwide
• most MS protein analyses require extraction then digestion of proteins prior to processing
• PCT offers significantly better protein extraction and digestion than current methods
• In scientific research, quality counts even if it is more expensive
We Further Believe:
• an average client would require one Barocycler 2320EXTREME ($30,000) and use ~
$12,000/year in consumables
• if PBI achieved 20% (minimum) market share over five years
• 3,200 customers x $30,000/instrument (net) = $96M total, or $19.2M/yr
• 3,200 customers x $12,000/yr in consumables (net) = $38.4M/yr (recurring revenue)
21. • Exclusive, 2-Year, WW, Co-Marketing Agreement with Global Leader SCIEX
• 100% of Floorless Debt Eliminated; $2M Line Closed; $610K PIPE Close
• 2017 M$S Expansion: 4+ Additions in Sales & Marketing
• Company Expects Continued Strong Revenue Growth
• Next Generation Barocycler 2320EXTREME Completed & Released (June 2016)
• Barocycler 2320EXT Units to be Used in “Cancer Moonshot” initiative
• Company Expects Collaborations with Key Opinion Leaders to Continue, Grow
• Company Expects Revenue Growth to be Driven by:
• New Micro-Pestle Consumable
• Just Released Next Generation Barocycler 2320EXTREME
• New Focus on Barozyme HT48 & Barocycler HUB Instruments in 2017
• SCIEX Co-Marketing Agreement
• Additions to the Sales & Marketing Team in 2017
Short-term Growth Drivers
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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.