Startup Investor Pitch
Byron Shen, PhD MBA
CEO, Velox Biosystems
bshen@veloxbio.com
Back in the 1480s,
Christopher Columbus had a “Startup Pitch”
“The Travels of Marco Polo” -
Columbus's copy with his
handwritten notes
• The Opportunity:
• Spices in the Indies, Silk from Cathay
• The Problem:
• Under the Pax Mongolica over Asia, Europeans had
access to the Indies/Cathay via a land passage
• Marco Polo and the Silk Road
• But with the fall of Constantinople to the Ottomans
in 1453, the land route to Asia became unavailable
to the Europeans
• The Pitch by Christopher Columbus:
• The Columbus brothers proposed to find a western
sea passage to reach Cathay and the Indies
(Image credit: Wikipedia)
Columbus’ Hypotheses & Assumptions
Toscanelli’s map of the Atlantic Ocean
(superimposed on a modern map)
• “The Earth is not flat”
• Known since the time of Aristotle
• 3rd century BC. Eratosthenes computed the
circumference of the Earth
• 9th century. Alfraganus estimated a degree
of latitude (or longitude) is 56⅔ miles
• Map of the Atlantic Ocean by Toscanelli
(1397 – 1482)
• Columbus’ calculations
• He estimated the Earth is 30,200 km in
circumference
• He estimated the distance from the Canary
Islands to Japan to be about 3,700 km!
(Image credit: Wikipedia)
Pitching to “Investors”
• In 1485, Columbus presented his plans to King John II of Portugal
• In 1486, Columbus presented his plans to Queen Isabella of Spain
• In both cases, due diligence/expert opinion = Columbus’s idea impractical
• In 1488, Columbus again appealed to the court of Portugal
• But the Competition! Portuguese explorers developed the southeast passage to Asia around Africa. In
1488 Bartolomeu Dias reached the Cape of Good Hope.
• … he also appealed to Genoa and Venice, the court of Henry VII of England…. With no success
• But in 1489, Spain gave him some seed money (some annual allowance & free stuff)
• He finally succeeded in 1492 with a Term Sheet with the Spanish crown:
• The rank of Admiral of the Ocean Sea; Viceroy and Governor of all the new lands he could claim for Spain
• He had the right to nominate 3 persons, and the sovereigns would choose one, for any office in the new lands
• 10% of all the revenues from the new lands in perpetuity, and the option to buy 1/8 interest in any
commercial venture with the new lands and receive 1/8 of the profits.
(Image credit: Wikipedia)
(Image credit: requestreduce.org)
1st landing Oct. 1492
& the rest is History…
The Startup Journey The Obstacle Course
(Image credit: redbull.com)
Different Types of Pitches
1. The speed-dating pitch
2. The Pitch/Investor Deck
➔ The due diligence discussion
“Velox Biosystems Wins Big at UC Entrepreneur Pitch Competition”
Rapid
Accurate
Point-of-Care
Urinary Tract Infection
Sepsis
Cancer
Rapid Screening Device
Antibiotic Sensitivity Test
Device
High-volume Consumables
Different Types of Pitches
1. The speed-dating pitch
2a. Executive Summary
2b. The Pitch/Investor Deck
➔ due diligence discussion
Startup Investor Deck
- Compelling, Convincing, and
“Comprehensive (enough)”
- Key Information for Investors
Your Investor Deck - Key Elements
1. The problem you are solving
2. The size of the opportunity
3. The level of competition
4. Your solution and differentiation
5. Your team (strength, experience, etc.)
6. Current status (IP, early data, prototype, etc.)
7. High level financials (the underlying assumptions)
8. Use of the funding
9. Your roadmap (key milestones, timeline, etc.)
10.Potential future exits (and returns) for investors
Examples: Velox Pitch Deck
• Narrative structure
• Company/Mission – Unmet Need – Solution –
Data – Competition – Market Opportunity –
Pipeline – Team – Roadmap/Milestones
• Appendix (supporting data slides/details)
• Navigation tabs/ribbon
• shows where you are in the pitch deck
• easy navigation back and forth
There are still several fundamental challenges in healthcare today which seriously affect the correct
diagnosis and timely treatment of medical problems. This is especially true in the areas we are
working on: urinary tract infection (UTI), sepsis, and cancer early detection, where existing
technologies can only target either speed or accuracy, but not both, or sometimes they just cannot
"find that needle in a hay stack".
Our rapid, ultra-sensitive detection technology is able to identify and quantify the presence of
disease at the single-cell or single-target level; provide both speed and accuracy that is not
available today; and we can "find that needle in a hay stack".
We have already developed product prototype and have very exciting clinical data to show we can
create game-changing solutions and make a big difference in medical diagnosis. And we have a
great team to make it happen, and we will become a company with value in $billions in the future.
Contact: Byron Shen, PhD MBA (bshen@veloxbio.com)
“Discover possibilities that were once impossible”
Velox Core Technology/Value Proposition
• 3D rapid detection platform:
• Culture-free pathogen detection
• Digital droplet molecular detection
• Ability to achieve exceptional sensitivity
and rapid speed in combination
• Antibiotic resistance is one of the most urgent
threats to public health (CDC)
• In UTI, there is a rapid increase of resistance (even
in the U.S.) due to high prevalence/recurrence,
high misdiagnosis, and empirical use of antibiotics
• High prevalence/recurrence rate
• High false positives (30-50%) in Dx
• Testing for antibiotic resistance takes at least
2-3 days currently
• 2nd most common type of infection in the body (NIH)
• 150 million UTI cases/year global (2001)
• 40-60% women will get UTI at least once;
25% women will experience recurrent UTIs (NIH)
• All pregnant women should be screened for UTIs
• 52% increase in hospitalization due to UTIs
• 15+% annual growth in US
• $6 billion in healthcare expense w.w. (AUA)
• Patented detection principle is
an elegant solution for high
throughput scanning of large
sample volumes
• Virtually zero sample processing
• Direct enumeration of bacteria
(much more sensitive than
indirect methods)
UTI Rapid Screening
Sample-to-Answer in 10 minutes
Significant improvement in diagnostic accuracy
Point-of-care Antibiotic Susceptibility Test
Sample-to-Answer in 2 hours
Phenotypic AST against a panel of common UTI antibiotics
Targeted antibiotic Rx in the same day
Cloud-based Local Resistance Rate Surveillance
Antibiotic resistance monitoring/tracking
Velox
Prototype
Device
Check out the 2-minute Velox pitch video by clicking here:
http://www.veloxbio.com/video/
R² = 1.00
1
10
100
1000
10000
1E+0 1E+1 1E+2 1E+3 1E+4 1E+5 1E+6 1E+7
AverageNumberofHits/90sec
Particle Concentration (particles/mL)
Highly Accurate Bacterial Quantification Phenotypic Antibiotic Susceptibility Test
UTI Rapid Screening
• Clinical feasibility study (n = 500)
• Superior accuracy - False positives 6.7%; False negatives 1.2%
• For Dipstick - False positives 34–49%; False negatives 6-26%
Antibiotic Susceptibility Test
• Clinical feasibility study (n = 60)
• Accuracy (categorical agreement) already surpasses 90%
• Enables clinicians to make informed antibiotic decision at the point-of-care
Further development to optimize product/clinical performance
See Data
Table 1
See Data
Table 2
Urology specialist: “this product certainly has the opportunity to be a game changer in this space.”
Point-of-
care
< 10
minutes
Accuracy
> 90%
< 2 hours
Accuracy
> 90%
VELOX Biosystems ✓ ✓ ✓ ✓ ✓
Dipstick ✓ ✓
Urine Culture ✓ ✓
Microscopic Analysis ✓
Clinical laboratory systems
(Beckman Coulter,
BioMérieux, BD, etc.)
✓ ✓
Click here for
detailed comparison
• Currently there is no such product in the
point-of-care space
• An in-depth competitive analysis shows
most other technological approaches may
not be practical for point-of-care
applications
• Clinicians are actively looking for solutions
to fill this unmet clinical need
✓ Primary Care/Urgent Care
✓ Urology
✓ OB-GYN
✓ Emergency Medicine
Total Available Market > $1 billion
• U.S. market:
• >11 million UTI outpatient cases/year
(suspected cases even higher)
• 5 million intended pregnancies/year;
average 2-3 screenings per pregnancy
• U.S. point-of-care TAM > $400M
• Global market: > $1 billion
Go-to-market Strategy
• Selling to clinics directly in key market
segments where the demand for point-of-
care testing is highest
• “Razor/razorblade business” model: PoC
analyzer device + high volume consumable
test kit sales
In-depth Market Research Survey with 50 Physicians
The Velox UTI Product is viewed very positively by all clinician
groups, with high scores on “interest level”, “meets unmet need”,
“improving patient outcomes”, “innovation”, “likelihood of purchase”,
and “likelihood of becoming a standard of care”.
Clinicians also indicate that a very high percentage of their UTI
patients would benefit from the Velox UTI Product:
• Primary Care/Urgent care: >90% of UTI patients
• Urology: >80% of UTI patients
• OB-GYN: >93% of UTI patients
• Emergency: >70% of UTI patients
Clinicians consider both Velox UTI Products
highly valuable for their clinical practice!
0
20
40
60
80
100
120
140
2020 2021 2022 2023
UTI Sales Revenue Projection ($millions)
US Europe Asia ROW
UTI product introduction in
early 2020; revenue
projection for 2020 - 2023
Potential additional revenue
from cancer liquid biopsy
product by 2022
Potential additional revenue
from bloodstream infection
product by 2023
Potential additional revenue
from partnership projects
UTI
Screening
Prod
UTI AST
Prod
Cancer LBx BSI/Sepsis
Cancer liquid biopsy
• Market opportunity est. $1.9B in 2022 (bcc Research)
• Velox IC3D Digital Droplet Technology can achieve >> 10x
improvement in detection sensitivity
• Scientific publications (Lab on a Chip)
• Development plan prepared (including clinical study plan) for
colorectal cancer liquid biopsy
Bloodstream Infection/Sepsis
• Market opportunity est. $1.4B in 2023 (Kalorama)
• $5M NIH collaborative research project with UC Irvine
• Scientific publications (Nature Communications)
Food Safety (upstream application)
• Feasibility study completed
• Potential partnership opportunity with other companies in the food
safety space
Core Competency
• Microbiology, Molecular biology, Immunology, Cancer biology,
Chemistry, Microfluidics, Fluorescence detection, Instrumentation,
Regulatory
• Ability to leverage UC Irvine resources/expertise
Current IP
• Encapsulated sensors and sensing systems for bioassays and
diagnostics
• Methods and devices for characterizing particles in clear and turbid
media
• Droplet-trapping devices for bioassays and diagnostics
New IP (to be filed)
• New detection technologies
• Application/product embodiment
Tim Abram, PhD
• Velox Director of R&D
• Biomedical engineering and
system integration
• Medical device and Dx
startup experience
Byron Shen, PhD MBA
• Velox CEO
• 25 years in medical device,
pharma/biotech, diagnostics
• Fortune 100 and mid/small
companies experience
Prof. Weian Zhao, UC Irvine
• Velox Founder & Sci. Advisor
• UCI Zhao Lab (30 people)
• MIT Technology Review TR35
• NIH Director’s New Innovator
Award
$2M seed money (angel and VC investors)
• Velox lab/operation set up in April 2017
• $5M NIH R01 grant (with UC Irvine)
• UTI technical and clinical feasibility demonstrated
• R&D pipeline with other high impact applications
• Key partnership projects established
Planning $6M Series A raise in early 2019
• Complete 1st UTI product development and clinical trial
• CE mark/510(k) regulatory submission in 12-18 mos.
• UTI Screening product intro in 2020, followed by UTI AST
product 6-12 mos. later
• On-going R&D pipeline activities
IPO or M&A exit for investors
Platform
Technology
Fundraise complete 3 mo. 6 mo. 9 mo. 12 mo.
Velox Data Slides
*If you are interested, here are 5 data slides including more details
about clinical feasibility data, concept validation with clinicians, and competitive analysis
• Diagnostic performance using a simple CFU/ml threshold cutoff is already far superior than that of dipstick. Diagnostic
accuracy (especially specificity) can be further improved by applying an intermediate zone for data analysis/report.
• Both analytical methods result in an excellent NPV, demonstrating the value for a rule-out test.
Sens (%) Spec (%) PPV (%) NPV (%) FPR (%) FNR (%)
Intermediate zone:
1-5x105 CFU/mL
98.7 93.3 79.4 99.7 6.7 1.2
No Intermediate zone
(Cutoff = 105 CFU/mL)
99.0 77.4 53.8 99.7 22.6 0.99
Intermediate zone: 1-5x105 No Intermediate zone (Cutoff = 105)
(n = 397) Culture + Culture - (n = 481) Culture + Culture -
Velox + 81 21 Velox + 100 86
Velox - 1 294 Velox - 1 294
N
VME*
(%)
ME**
(%)
Categorical
Agreement***
(%)
Sensitivity
(%)
Specificity
(%)
COMBO 107 1.87 4.67 93.5 94.0 91.3
AX 20 0 0 100 100 100
CP 25 4.00 0 96.0 100 87.5
CZ 24 0 4.17 95.8 94.7 100
GM 22 4.54 9.09 86.4 88.2 80.0
NF 16 0 12.5 87.5 86.7 100.0
*VME – very major error (reference category result is R and new device result is S)
**ME – major error (reference category result is S and new device result is R)
***FDA guidelines require Categorical Agreement to exceed 90%
Sensitivity and Specificity here may also be considered as “True Susceptible Rate” and “True Resistant Rate”, respectively
Technology Advantages Disadvantages Point-of-care AST
Dipstick Point-of-care; easy to use; inexpensive High FPR and FNR; no AST No
Conventional urine culture +
ID + AST
Sensitive; comprehensive info; Time consuming; lab-based No
Urinalysis and microscopy Fast; relatively inexpensive No AST No
MALDI-TOF Rapid and sensitive, potential for AST Expensive equipment, not practical for point-of-care No
PCR Good sensitivity; bacteria ID; some
AST info
Extensive sample processing; expensive to cover all AMR genetic
markers; genotyping /= phenotyping
No
Fluorescent in situ
hybridization (FISH)
Good sensitivity; bacteria ID; potential
for AST assay
Sample processing; expensive to cover all AMR genetic markers;
genotyping /= phenotyping
No
Microfluidics Potentially more rapid with minimal
sample processing, small footprint
May be challenging in engineering complexity, assay cost, LOD No
Immunological-based assay Rapid and inexpensive Poor specificity and sensitivity; No AST No
Forward light scattering
(current embodiment)
Inexpensive, with potential for AST LOD, specificity somewhat lacking; take 3 hrs for bacteria
detection
No
Primary care/
urgent care
Urology OB-GYN Emergency
Medicine*
Interest level 4.5 4.6 4.4 3.9
Meets unmet need 4.2 4.5 4.3 3.6
Improving patient
outcome
4.5 4.5 4.1 4
Likelihood of purchase 4 4.2 4.1 3.5
Innovation 4.4 4.3 4.2 4.5
Likelihood of becoming a
standard of care
4.2 4.4 4.1 3.5
(N = 50 clinicians; weighted
average in each group)
5 = Strongly Agree
4 = Agree
3 = Neutral
2 = Disagree
1 = Strongly Disagree
• (Primary care/urgent care) “It is a great tool. Very helpful to determine presence of uti and guide initial tx. 2 hour
AST turnaround would be a fantastic event for my patients.”
• (Urology) “This would be great. We are in significant need for a way to better utilize or not utilize abx.”
• (OB-GYN) “This would be an amazing tool. Practical and convenient with the potential for improved patient care.”
• (ER*) “Sounds absolutely amazing, especially for diabetics and/or those with recurrent UTI whom we know have had
antibiotic resistant organisms in the past!”
*Note: In general, ER clinicians place
very high value on the 10-min UTI
Screening, but feel the 2-hr AST is on
the long side for the ER setting.
Thank you, and Q&A
Yeah!
Byron Shen, PhD MBA
CEO, Velox Biosystems
bshen@veloxbio.com

Ten Pointers for the Perfect Pitch

  • 1.
    Startup Investor Pitch ByronShen, PhD MBA CEO, Velox Biosystems bshen@veloxbio.com
  • 2.
    Back in the1480s, Christopher Columbus had a “Startup Pitch” “The Travels of Marco Polo” - Columbus's copy with his handwritten notes • The Opportunity: • Spices in the Indies, Silk from Cathay • The Problem: • Under the Pax Mongolica over Asia, Europeans had access to the Indies/Cathay via a land passage • Marco Polo and the Silk Road • But with the fall of Constantinople to the Ottomans in 1453, the land route to Asia became unavailable to the Europeans • The Pitch by Christopher Columbus: • The Columbus brothers proposed to find a western sea passage to reach Cathay and the Indies (Image credit: Wikipedia)
  • 3.
    Columbus’ Hypotheses &Assumptions Toscanelli’s map of the Atlantic Ocean (superimposed on a modern map) • “The Earth is not flat” • Known since the time of Aristotle • 3rd century BC. Eratosthenes computed the circumference of the Earth • 9th century. Alfraganus estimated a degree of latitude (or longitude) is 56⅔ miles • Map of the Atlantic Ocean by Toscanelli (1397 – 1482) • Columbus’ calculations • He estimated the Earth is 30,200 km in circumference • He estimated the distance from the Canary Islands to Japan to be about 3,700 km! (Image credit: Wikipedia)
  • 4.
    Pitching to “Investors” •In 1485, Columbus presented his plans to King John II of Portugal • In 1486, Columbus presented his plans to Queen Isabella of Spain • In both cases, due diligence/expert opinion = Columbus’s idea impractical • In 1488, Columbus again appealed to the court of Portugal • But the Competition! Portuguese explorers developed the southeast passage to Asia around Africa. In 1488 Bartolomeu Dias reached the Cape of Good Hope. • … he also appealed to Genoa and Venice, the court of Henry VII of England…. With no success • But in 1489, Spain gave him some seed money (some annual allowance & free stuff) • He finally succeeded in 1492 with a Term Sheet with the Spanish crown: • The rank of Admiral of the Ocean Sea; Viceroy and Governor of all the new lands he could claim for Spain • He had the right to nominate 3 persons, and the sovereigns would choose one, for any office in the new lands • 10% of all the revenues from the new lands in perpetuity, and the option to buy 1/8 interest in any commercial venture with the new lands and receive 1/8 of the profits.
  • 5.
    (Image credit: Wikipedia) (Imagecredit: requestreduce.org) 1st landing Oct. 1492 & the rest is History…
  • 6.
    The Startup JourneyThe Obstacle Course (Image credit: redbull.com)
  • 7.
    Different Types ofPitches 1. The speed-dating pitch 2. The Pitch/Investor Deck ➔ The due diligence discussion “Velox Biosystems Wins Big at UC Entrepreneur Pitch Competition”
  • 8.
  • 10.
  • 13.
    Rapid Screening Device AntibioticSensitivity Test Device High-volume Consumables
  • 14.
    Different Types ofPitches 1. The speed-dating pitch 2a. Executive Summary 2b. The Pitch/Investor Deck ➔ due diligence discussion
  • 15.
    Startup Investor Deck -Compelling, Convincing, and “Comprehensive (enough)” - Key Information for Investors
  • 16.
    Your Investor Deck- Key Elements 1. The problem you are solving 2. The size of the opportunity 3. The level of competition 4. Your solution and differentiation 5. Your team (strength, experience, etc.) 6. Current status (IP, early data, prototype, etc.) 7. High level financials (the underlying assumptions) 8. Use of the funding 9. Your roadmap (key milestones, timeline, etc.) 10.Potential future exits (and returns) for investors
  • 17.
    Examples: Velox PitchDeck • Narrative structure • Company/Mission – Unmet Need – Solution – Data – Competition – Market Opportunity – Pipeline – Team – Roadmap/Milestones • Appendix (supporting data slides/details) • Navigation tabs/ribbon • shows where you are in the pitch deck • easy navigation back and forth
  • 19.
    There are stillseveral fundamental challenges in healthcare today which seriously affect the correct diagnosis and timely treatment of medical problems. This is especially true in the areas we are working on: urinary tract infection (UTI), sepsis, and cancer early detection, where existing technologies can only target either speed or accuracy, but not both, or sometimes they just cannot "find that needle in a hay stack". Our rapid, ultra-sensitive detection technology is able to identify and quantify the presence of disease at the single-cell or single-target level; provide both speed and accuracy that is not available today; and we can "find that needle in a hay stack". We have already developed product prototype and have very exciting clinical data to show we can create game-changing solutions and make a big difference in medical diagnosis. And we have a great team to make it happen, and we will become a company with value in $billions in the future. Contact: Byron Shen, PhD MBA (bshen@veloxbio.com) “Discover possibilities that were once impossible”
  • 20.
    Velox Core Technology/ValueProposition • 3D rapid detection platform: • Culture-free pathogen detection • Digital droplet molecular detection • Ability to achieve exceptional sensitivity and rapid speed in combination
  • 21.
    • Antibiotic resistanceis one of the most urgent threats to public health (CDC) • In UTI, there is a rapid increase of resistance (even in the U.S.) due to high prevalence/recurrence, high misdiagnosis, and empirical use of antibiotics • High prevalence/recurrence rate • High false positives (30-50%) in Dx • Testing for antibiotic resistance takes at least 2-3 days currently • 2nd most common type of infection in the body (NIH) • 150 million UTI cases/year global (2001) • 40-60% women will get UTI at least once; 25% women will experience recurrent UTIs (NIH) • All pregnant women should be screened for UTIs • 52% increase in hospitalization due to UTIs • 15+% annual growth in US • $6 billion in healthcare expense w.w. (AUA)
  • 22.
    • Patented detectionprinciple is an elegant solution for high throughput scanning of large sample volumes • Virtually zero sample processing • Direct enumeration of bacteria (much more sensitive than indirect methods)
  • 23.
    UTI Rapid Screening Sample-to-Answerin 10 minutes Significant improvement in diagnostic accuracy Point-of-care Antibiotic Susceptibility Test Sample-to-Answer in 2 hours Phenotypic AST against a panel of common UTI antibiotics Targeted antibiotic Rx in the same day Cloud-based Local Resistance Rate Surveillance Antibiotic resistance monitoring/tracking Velox Prototype Device Check out the 2-minute Velox pitch video by clicking here: http://www.veloxbio.com/video/
  • 24.
    R² = 1.00 1 10 100 1000 10000 1E+01E+1 1E+2 1E+3 1E+4 1E+5 1E+6 1E+7 AverageNumberofHits/90sec Particle Concentration (particles/mL) Highly Accurate Bacterial Quantification Phenotypic Antibiotic Susceptibility Test
  • 25.
    UTI Rapid Screening •Clinical feasibility study (n = 500) • Superior accuracy - False positives 6.7%; False negatives 1.2% • For Dipstick - False positives 34–49%; False negatives 6-26% Antibiotic Susceptibility Test • Clinical feasibility study (n = 60) • Accuracy (categorical agreement) already surpasses 90% • Enables clinicians to make informed antibiotic decision at the point-of-care Further development to optimize product/clinical performance See Data Table 1 See Data Table 2 Urology specialist: “this product certainly has the opportunity to be a game changer in this space.”
  • 26.
    Point-of- care < 10 minutes Accuracy > 90% <2 hours Accuracy > 90% VELOX Biosystems ✓ ✓ ✓ ✓ ✓ Dipstick ✓ ✓ Urine Culture ✓ ✓ Microscopic Analysis ✓ Clinical laboratory systems (Beckman Coulter, BioMérieux, BD, etc.) ✓ ✓ Click here for detailed comparison
  • 27.
    • Currently thereis no such product in the point-of-care space • An in-depth competitive analysis shows most other technological approaches may not be practical for point-of-care applications • Clinicians are actively looking for solutions to fill this unmet clinical need ✓ Primary Care/Urgent Care ✓ Urology ✓ OB-GYN ✓ Emergency Medicine Total Available Market > $1 billion • U.S. market: • >11 million UTI outpatient cases/year (suspected cases even higher) • 5 million intended pregnancies/year; average 2-3 screenings per pregnancy • U.S. point-of-care TAM > $400M • Global market: > $1 billion Go-to-market Strategy • Selling to clinics directly in key market segments where the demand for point-of- care testing is highest • “Razor/razorblade business” model: PoC analyzer device + high volume consumable test kit sales
  • 28.
    In-depth Market ResearchSurvey with 50 Physicians The Velox UTI Product is viewed very positively by all clinician groups, with high scores on “interest level”, “meets unmet need”, “improving patient outcomes”, “innovation”, “likelihood of purchase”, and “likelihood of becoming a standard of care”. Clinicians also indicate that a very high percentage of their UTI patients would benefit from the Velox UTI Product: • Primary Care/Urgent care: >90% of UTI patients • Urology: >80% of UTI patients • OB-GYN: >93% of UTI patients • Emergency: >70% of UTI patients Clinicians consider both Velox UTI Products highly valuable for their clinical practice!
  • 29.
    0 20 40 60 80 100 120 140 2020 2021 20222023 UTI Sales Revenue Projection ($millions) US Europe Asia ROW UTI product introduction in early 2020; revenue projection for 2020 - 2023 Potential additional revenue from cancer liquid biopsy product by 2022 Potential additional revenue from bloodstream infection product by 2023 Potential additional revenue from partnership projects UTI Screening Prod UTI AST Prod Cancer LBx BSI/Sepsis
  • 30.
    Cancer liquid biopsy •Market opportunity est. $1.9B in 2022 (bcc Research) • Velox IC3D Digital Droplet Technology can achieve >> 10x improvement in detection sensitivity • Scientific publications (Lab on a Chip) • Development plan prepared (including clinical study plan) for colorectal cancer liquid biopsy Bloodstream Infection/Sepsis • Market opportunity est. $1.4B in 2023 (Kalorama) • $5M NIH collaborative research project with UC Irvine • Scientific publications (Nature Communications) Food Safety (upstream application) • Feasibility study completed • Potential partnership opportunity with other companies in the food safety space
  • 31.
    Core Competency • Microbiology,Molecular biology, Immunology, Cancer biology, Chemistry, Microfluidics, Fluorescence detection, Instrumentation, Regulatory • Ability to leverage UC Irvine resources/expertise Current IP • Encapsulated sensors and sensing systems for bioassays and diagnostics • Methods and devices for characterizing particles in clear and turbid media • Droplet-trapping devices for bioassays and diagnostics New IP (to be filed) • New detection technologies • Application/product embodiment
  • 32.
    Tim Abram, PhD •Velox Director of R&D • Biomedical engineering and system integration • Medical device and Dx startup experience Byron Shen, PhD MBA • Velox CEO • 25 years in medical device, pharma/biotech, diagnostics • Fortune 100 and mid/small companies experience Prof. Weian Zhao, UC Irvine • Velox Founder & Sci. Advisor • UCI Zhao Lab (30 people) • MIT Technology Review TR35 • NIH Director’s New Innovator Award
  • 33.
    $2M seed money(angel and VC investors) • Velox lab/operation set up in April 2017 • $5M NIH R01 grant (with UC Irvine) • UTI technical and clinical feasibility demonstrated • R&D pipeline with other high impact applications • Key partnership projects established Planning $6M Series A raise in early 2019 • Complete 1st UTI product development and clinical trial • CE mark/510(k) regulatory submission in 12-18 mos. • UTI Screening product intro in 2020, followed by UTI AST product 6-12 mos. later • On-going R&D pipeline activities IPO or M&A exit for investors Platform Technology
  • 34.
    Fundraise complete 3mo. 6 mo. 9 mo. 12 mo.
  • 35.
    Velox Data Slides *Ifyou are interested, here are 5 data slides including more details about clinical feasibility data, concept validation with clinicians, and competitive analysis
  • 36.
    • Diagnostic performanceusing a simple CFU/ml threshold cutoff is already far superior than that of dipstick. Diagnostic accuracy (especially specificity) can be further improved by applying an intermediate zone for data analysis/report. • Both analytical methods result in an excellent NPV, demonstrating the value for a rule-out test. Sens (%) Spec (%) PPV (%) NPV (%) FPR (%) FNR (%) Intermediate zone: 1-5x105 CFU/mL 98.7 93.3 79.4 99.7 6.7 1.2 No Intermediate zone (Cutoff = 105 CFU/mL) 99.0 77.4 53.8 99.7 22.6 0.99 Intermediate zone: 1-5x105 No Intermediate zone (Cutoff = 105) (n = 397) Culture + Culture - (n = 481) Culture + Culture - Velox + 81 21 Velox + 100 86 Velox - 1 294 Velox - 1 294
  • 37.
    N VME* (%) ME** (%) Categorical Agreement*** (%) Sensitivity (%) Specificity (%) COMBO 107 1.874.67 93.5 94.0 91.3 AX 20 0 0 100 100 100 CP 25 4.00 0 96.0 100 87.5 CZ 24 0 4.17 95.8 94.7 100 GM 22 4.54 9.09 86.4 88.2 80.0 NF 16 0 12.5 87.5 86.7 100.0 *VME – very major error (reference category result is R and new device result is S) **ME – major error (reference category result is S and new device result is R) ***FDA guidelines require Categorical Agreement to exceed 90% Sensitivity and Specificity here may also be considered as “True Susceptible Rate” and “True Resistant Rate”, respectively
  • 38.
    Technology Advantages DisadvantagesPoint-of-care AST Dipstick Point-of-care; easy to use; inexpensive High FPR and FNR; no AST No Conventional urine culture + ID + AST Sensitive; comprehensive info; Time consuming; lab-based No Urinalysis and microscopy Fast; relatively inexpensive No AST No MALDI-TOF Rapid and sensitive, potential for AST Expensive equipment, not practical for point-of-care No PCR Good sensitivity; bacteria ID; some AST info Extensive sample processing; expensive to cover all AMR genetic markers; genotyping /= phenotyping No Fluorescent in situ hybridization (FISH) Good sensitivity; bacteria ID; potential for AST assay Sample processing; expensive to cover all AMR genetic markers; genotyping /= phenotyping No Microfluidics Potentially more rapid with minimal sample processing, small footprint May be challenging in engineering complexity, assay cost, LOD No Immunological-based assay Rapid and inexpensive Poor specificity and sensitivity; No AST No Forward light scattering (current embodiment) Inexpensive, with potential for AST LOD, specificity somewhat lacking; take 3 hrs for bacteria detection No
  • 40.
    Primary care/ urgent care UrologyOB-GYN Emergency Medicine* Interest level 4.5 4.6 4.4 3.9 Meets unmet need 4.2 4.5 4.3 3.6 Improving patient outcome 4.5 4.5 4.1 4 Likelihood of purchase 4 4.2 4.1 3.5 Innovation 4.4 4.3 4.2 4.5 Likelihood of becoming a standard of care 4.2 4.4 4.1 3.5 (N = 50 clinicians; weighted average in each group) 5 = Strongly Agree 4 = Agree 3 = Neutral 2 = Disagree 1 = Strongly Disagree • (Primary care/urgent care) “It is a great tool. Very helpful to determine presence of uti and guide initial tx. 2 hour AST turnaround would be a fantastic event for my patients.” • (Urology) “This would be great. We are in significant need for a way to better utilize or not utilize abx.” • (OB-GYN) “This would be an amazing tool. Practical and convenient with the potential for improved patient care.” • (ER*) “Sounds absolutely amazing, especially for diabetics and/or those with recurrent UTI whom we know have had antibiotic resistant organisms in the past!” *Note: In general, ER clinicians place very high value on the 10-min UTI Screening, but feel the 2-hr AST is on the long side for the ER setting.
  • 41.
    Thank you, andQ&A Yeah! Byron Shen, PhD MBA CEO, Velox Biosystems bshen@veloxbio.com